Enrolling in a Study or Clinical Trial, Retina Eye Diseases

DRCR Protocol AG

South Region Patients

Randomized Clinical Trial Assessing the effects of Pneumatic Vitreolysis on Vitreomacular Traction (Protocol AG)

General Information

We are taking part in a study to determine the effects of a new treatment on a condition called Vitreomacular Traction (VMT). This study is being conducted by the DRCR Network, which is a group of clinical sites dedicated to research of retinal diseases. This Network includes over 100 eye centers in the United States and Canada. The DRCR Network started over 15 years ago and has conducted over 25 studies on retinal disease. The study is being paid for by the National Eye Institute (NEI), one of the National Institutes of Health (NIH). The NIH is a branch of the U.S. Department of Health and Human Services that funds medical research. This briefly describes the study and what is involved if you take part. If you think you might be interested in taking part in the study, you will be given a document called an Informed Consent Form, which will provide a written explanation of the study in more detail. We will discuss the study with you and answer any questions you have. You will be given as much time as you may need to decide if you want to take part in the study.

What is vitreomacular traction (VMT)?

The vitreous is the clear, gel-like substance that fills the inside of the eyeball. The macula is the center part of the retina that is responsible for sharp, straight-ahead vision. In VMT, the vitreous is abnormally attached or stuck to the macula. As the vitreous gel separates from the retina due to normal aging, the abnormal attachment can lead to traction or pulling on the macula. The pulling causes swelling and abnormal elevation of the macula that leads to a decrease or distortion in vision.

How is VMT usually treated?

Current treatments for VMT include surgery to remove the vitreous (“vitrectomy”) which will relieve the traction, an injection of ocriplasmin (Jetrea®), or waiting to see if the VMT resolves on its own.

What is the goal of this study?

The purpose of this study is to find out if another treatment using injection of a gas bubble into the eye results in release of VMT more often than observation.

What treatment is being used in this study?

The treatment used in this study is a gas called perfluoropropane or C3F8. Injections into the eye of C3F8 gas have been approved by the U.S. Food and Drug Administration for a procedure called pneumatic retinopexy, which is a treatment for certain types of retinal detachment. These C3F8 gas injections into the eye have been used by retina specialists for more than 30 years to treat retinal detachment. Gas injections have not been approved for treating VMT. Therefore, gas injections in this study are considered experimental. Injection of C3F8 has been used in some patients with VMT to try to cause release of the traction sooner than watching and waiting.

Who can participate in the study?

Participants must be 18 years or older and have VMT without a macular hole that meets certain criteria. To take part, you must be willing to avoid high altitude travel and avoid lying on your back (unless you have had prior cataract surgery) until the gas bubble goes away (up to 8 weeks). You also cannot receive nitrous oxide anesthesia while the gas bubble is present.

What treatment will I receive if I take part in the study?

If you take part in the study, your treatment will be determined by chance. You will receive one of the following two treatment approaches:

1) Injection of C3F8 gas bubble at the start of the study
2) Sham injection

“Sham” means that a real injection is not given. You may not know whether you are receiving a “sham” injection or a gas injection. An additional procedure may be performed to remove fluid from the eye either before or after the injection to avoid or relieve pressure in the eye.

What are the possible serious side effects of the injection?

Possible serious side effects due to the gas injection itself include (1) bleeding in the eye,
(2)rise in eye pressure,
(3) macular hole,
(4) retinal tear or detachment,
(5) cataract,
or (6) endophthalmitis (infection of the eye).

These can be serious but they are very uncommon. Common but less serious side effects of the injection include pain, discomfort, redness, or itching lasting for a few days, and floaters. For some people the gas bubble may be visible for several weeks and may temporarily block central vision.

How long will the study last?

The study will last 6 months. First, your eye doctor will check if you are eligible for the study by performing an eye exam, a visual acuity test, a visual function test, and a measurement of the structure of the retina using a procedure called Optical Coherence Tomography (OCT). If you are eligible for the study, you will then be randomly assigned to either a gas or sham injection and will receive your assigned injection. Follow-up visits will take place after 1 week, 4 weeks, 12 weeks, and 24 weeks. If your condition worsens during the study, surgery may be done to remove the vitreous and relieve the traction.

What costs will be my responsibility?

The study will pay for vision testing at all visits, as well as the OCT and eye exam at all visits other than at 12 and 24 weeks. The 12 and 24 week visits are considered standard care visits. You or your insurance company will be billed for the OCT and eye exam at these visits. The study gas injection will be provided to you at no cost. Any additional tests and procedures not listed above will be billed to you or your insurance company like they normally would.

Depending on your insurance plan, it is possible that your insurance will not pay for some of the procedures and testing required for the study; if they do not pay, the study may become responsible for these costs if you have a financial hardship.

Is there payment for taking part in this study?

If you take part in the study, you will receive up to $150 for your participation. These payments will be paid as follows: $25 for each completed visit prior to 24 weeks (up to 4 visits), and $50 for the completed 24 week visit. These payments will be made by gift or money cards given to you by your study doctor’s office. If you withdraw from the study, you will still be paid for the visits that you have completed. You will not receive extra payments for visits that are required as part of your normal care or for visits that are for treating an illness or injury.

Will I be reimbursed for travel expenses?

The study may reimburse you for travel expenses if you have specific additional travel expenses above $25 that make it difficult for you to return for study visits.

What do I need to do to participate in the study?

You will be given an Informed Consent Form to read. This document will provide much greater detail about the study. If you would like to consider being in the study, we will first ask you to sign the form so that testing can be done to determine if you likely meet all of the eligibility criteria for the study. If you are eligible, we will again discuss the study and answer any questions you may have before you decide whether or not to enter the study.

Contact Us More Study Information

New patients interested in enrolling in this study, please send us an E-mail. Include your name, the reason of your interest in this study and the office location you receive treatment. You will receive a reply from us within 48 - 72 hours.

DRCR Protocol AH

South Region Patients

Single-Arm Study Assessing the Effects of Pneumatic Vitreolysis on Macular Hole (Protocol AH)

General Information

We are taking part in a study to determine the effects of a new treatment on a condition called a macular hole. This study is being conducted by the DRCR Network, which is a group of clinical sites dedicated to research of retinal diseases. This Network includes over 100 eye centers in the United States and Canada. The DRCR Network started over 15 years ago and has conducted over 25 studies on retinal disease. The study is being paid for by the National Eye Institute (NEI), one of the National Institutes of Health (NIH). The NIH is a branch of the U.S. Department of Health and Human Services that funds medical research. This briefly describes the study and what is involved if you take part. If you think you might be interested in taking part in the study, you will be given a document called an Informed Consent Form, which will provide a written explanation of the study in more detail. Your doctor and her/his staff will discuss the study with you and answer any questions you have. You will be given as much time as you may need to decide if you want to take part in the study.

What is a macular hole?

A macular hole is a small break in the light sensitive tissue of the eye that can result from a condition called vitreomacular traction (VMT). The vitreous is the clear, gel-like substance that fills the inside of the eyeball. The macula is the center part of the retina that is responsible for sharp, straight-ahead vision. In VMT, the vitreous is abnormally attached or stuck to the macula. As the vitreous gel separates from the retina due to normal aging, the abnormal attachment can lead to traction or pulling on the macula. The pulling causes swelling and abnormal elevation of the macula that leads to a decrease or distortion in vision.

How is a Macular Hole usually treated?

Current treatments for macular hole include surgery to remove the vitreous (“vitrectomy”) or an injection of ocriplasmin (Jetrea®).

What is the goal of this study?

The purpose of this study is to find out if another treatment using injection of a gas bubble into the eye results in release of VMT and healing of macular holes.

What treatment is being used in this study?

The treatment used in this study is a gas called perfluoropropane or C3F8. Injections into the eye of C3F8 gas have been approved by the U.S. Food and Drug Administration for a procedure called Pneumatic Retinopexy, which is a treatment for certain types of retinal detachment. These C3F8 gas injections into the eye have been used by retina specialists for more than 30 years to treat retinal detachment. Gas injections have not been approved for treating macular holes. Therefore, gas injections in this study are considered experimental. Injection of the gas bubble has been used in some patients with macular holes as an alternative to surgery.

Who can participate in the study?

Participants must be 18 years or older and have VMT with a macular hole that meets certain criteria. To take part, you must be willing to avoid high altitude travel and avoid lying on your back (unless you have had prior cataract surgery) until the gas bubble goes away (up to 8 weeks). You also be willing to position your head face down for at least half of the day for at least 4 days after the injection. You cannot receive nitrous oxide anesthesia while the gas bubble is present.

What treatment will I receive if I take part in the study?

If you take part in this study, you will receive an injection of C3F8 gas at the start of the study. An additional procedure may be performed to remove fluid from the eye either before or after the injection to avoid or relieve pressure in the eye.

What are the possible serious side effects of the injection?

Possible serious side effects due to the gas injection itself include (1) bleeding in the eye, (2) rise in eye pressure, (3) worsening of macular hole, (4) retinal tear or detachment, (5) cataract, or (6) endophthalmitis (infection of the eye). These can be serious but they are very uncommon. Common but less serious side effects of the injection include pain, discomfort, redness, or itching lasting for a few days, and floaters. The gas bubble may be visible for several weeks and may temporarily block central vision.

How long will the study last?

The study will last 6 months. First, your eye doctor will check if you are eligible for the study by performing an eye exam, a visual acuity test, and a measurement of the structure of the retina using a procedure called Optical Coherence Tomography (OCT). If you are eligible for the study, you will receive a gas injection. Follow-up visits will take place after 1 week, 4 weeks, 8 weeks, and 24 weeks. If your condition worsens during the study, surgery may be done to remove the vitreous and relieve the traction.

What costs will be my responsibility?

The study will pay for vision testing at all visits, as well as the OCT and eye exam at the enrollment and 1 week visits. The 4, 8 and 24 week visits are considered standard care visits. You or your insurance company will be billed for the OCT and eye exam at these visits. The study gas injection will be provided to you at no cost. Any additional tests and procedures not listed above will be billed to you or your insurance company like they normally would. Depending on your insurance plan, it is possible that your insurance will not pay for some of the procedures and testing required for the study; if they do not pay, the study may become responsible for these costs if you have a financial hardship.

Is there payment for taking part in this study?

If you take part in the study, you will receive up to $150 for your participation. These payments will be paid as follows: $25 for each completed visit for baseline, 1, 4, and 24 week visits, and $50 for the completed 8 week visit. These payments will be made by gift or money cards given to you by your study doctor’s office. If you withdraw from the study, you will still be paid for the visits that you have completed. You will not receive extra payments for visits that are required as part of your normal care or for visits that are for treating an illness or injury.

Will I be reimbursed for travel expenses?

The study may reimburse you for travel expenses if you have specific additional travel expenses above $25 that make it difficult for you to return for study visits.

What do I need to do to participate in the study?

You will be given an Informed Consent Form to read. This document will provide much greater detail about the study. If you would like to consider being in the study, we will first ask you to sign the form so that testing can be done to determine if you likely meet all of the eligibility criteria for the study. If you are eligible, we will again discuss the study and answer any questions you may have before you decide whether or not to enter the study.

Contact Us More Study Information

New patients interested in enrolling in this study, please send us an E-mail. Include your name, the reason of your interest in this study and the office location you receive treatment. You will receive a reply from us within 48 - 72 hours.

Protocol #KHB-1801 (Chengdu)

South Region Patients

A Multi-Center, Double Masked, Randomized, Dose-Ranging Trial to Evaluate Efficacy and Safety of Conbercept Intravitreal Injection in Subjects with Neovascular Age-Related Macular Degeneration (PANDA Study).

General Information

wAMD (wet Age-Related Macular Degeneration) is a leading cause of severe and irreversible vision loss. When left untreated, wAMD can progress, causing damage to the retina that may lead to scarring and loss of central vision. The Panda study is one way for you to assist researchers in their search to discover effective new treatments for wAMD.

What is the Purpose of the Panda study?

Researchers are studying an investigational drug called conbercept to see how safe and effective it is in treating patients with wAMD. They will do this by comparing it to another drug, aflibercept, already widely used by doctors to treat wAMD.

To pre-qualify for this research study, you must:

Be at least 50 years old.
Have newly diagnosed wAMD.
Have never received previous treatment for wAMD in the study eye.

There are several other requirements to qualify for this study. Your doctor will review your eligibility with you.

Will the study cost me anything?

There is no cost to PANDA study participants for the study drug or any study related procedure or exam.

How long will the study last?

We expect that your part in this research will last approximately 2 years from the Screening visit to the last follow-up visit.

Can I withdraw from the study?

Your participation in this study is voluntary. You may decide not to participate or you may withdraw your participation in the study at any time.

Contact Us More Study Information

New patients interested in enrolling in this study, please send us an E-mail. Include your name, the reason of your interest in this study and the office location you receive treatment. You will receive a reply from us within 48 - 72 hours.

DRCR Protocol W

South Region Patients

Intravitreous Anti-VEGF Treatment for Prevention of Vision Threatening Diabetic Retinopathy in Eyes at High Risk

A multi-center study being conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net) sponsored by the National Institutes of Health, the U.S. Department of Health and Human Services.

General Information for a Patient Who May Want to Be a Participant in this Study

Your eye doctor is taking part in a study being conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net). This Network includes over 100 eye centers in the United States and Canada that specialize in the care of patients with diabetic retinopathy.

The study is being funded by the National Eye Institute, which is a part of the National Institutes of Health, a branch of the U.S. Department of Health and Human Services that funds medical research, by the JDRF, and by Regeneron Pharmaceuticals, Inc., which is the company providing drug for this study.

If you have diabetic retinopathy and think you might be interested in taking part in the study, you will be given a document called an Informed Consent Form, which will provide a written explanation of the study in more detail. Your doctor and her/his staff will discuss the study with you and answer any questions you have. You will be given as much time as you may need to decide if you want to take part in the study. This manuscript will tell you about diabetic retinopathy and the treatments that are available as standard care.

Eyes with diabetic retinopathy like yours are at a high risk of developing two complications that can affect vision:
1) proliferative diabetic retinopathy (PDR) or
2) diabetic macular edema (DME).

Proliferative Diabetic Retinopathy (PDR) is a disease where new blood vessels and scar tissue form on the surface of the retina (the light sensitive tissue which lines the back of the eye), because of poor blood flow from diabetes. These new blood vessels can bleed into the middle of the eye or pull (detach) the retina off of the back wall of the eye.

This can lead to loss of vision or even blindness that cannot always be fixed even with the best treatments available. Diabetic Macular Edema (DME) is the term used for swelling in the small central part of the retina used for sharp straight-ahead vision due to diabetes. The blood vessels are weakened by diabetes and may become leaky.

This causes the retina to become thickened or swollen. Swelling of the central part of the retina could lead to decreased vision.

How are PDR and DME usually treated?

When vision is reduced from these complications, an injection into the eye may be given of a drug that blocks a substance called vascular endothelial growth factor (“anti-VEGF drug”).

Anti-VEGF drugs decrease the growth of new blood vessels and stop leakage of fluid. For eyes that are at high risk for developing these complications, the diabetic retinopathy is watched closely by an ophthalmologist but often not treated until it worsens to DME involving the center of the retina or advanced PDR, when these complications are likely to affect vision if left untreated.

What are the treatments being evaluated in this study?

We are doing a study to find out if periodic anti- VEGF injections into the eye can lower the chances of developing either PDR or DME. We [Protocol Version 1.0] Version 1.0 9/1/15 know that frequent injections can stabilize and sometimes improve vision in eyes that already have PDR or DME.

However, it is possible that the treatment will not bring all of the vision back that may have been lost from PDR or DME. Starting less frequent injections now may keep your eye from losing vision from PDR or DME. On the other hand, it is possible that infrequent injections may not prevent the development of PDR or DME or may not help your vision in the long run. It is also possible that you do not develop PDR or DME, even without injections.

Interested in this study and ready to enroll?

Click Here

What treatment will I receive if I take part in the study? If you take part in the study, your treatment will be determined by chance. You will receive one of the following two treatment approaches:
1) Periodic anti-VEGF injections from the beginning,
2) Sham injections (Observation) until the diabetic retinopathy has worsened to PDR or DME and then treating with anti-VEGF injections “Sham” means that a real injection is not given.
You may not know whether you are receiving a “sham” injection or an injection of drug. How the treatment is selected is described in more detail in the Informed Consent Form.

What is the drug being used in this study?

Eylea® is the anti-VEGF drug being used in this study. It has been approved by the FDA for DME and treatment of diabetic retinopathy in eyes with DME. It has not been approved for the treatment of diabetic retinopathy in eyes without DME. What is involved with injections in the eye? The injections are done through the white part of the eye with a needle which is about the size of a single hair. Before the injection is given, the surface of the white part of the eye is cleaned to prevent infection. Numbing medicine also is administered before the injection to numb the white part of the eye to minimize or eliminate any discomfort from the injection. When the injection is given, you typically will feel a slight pressure but this is usually not very painful because of the tiny size of the needle used. After the injection, you may have slight discomfort for a few days from the medicines used to clean the eye.

DRCR.net Conference in Houston, Texas

drcr network, collaborative, dedicated, protocol w

DRCR.net summer meeting attended by our Research Coordinator, Elaine R., covering Protocol W, Protocol AC, Protocol AD, and the new Protocol, which got certified the weekend of August 11th 2018, for Protocol AG and Protocol AH on VMT and macular holes.

About DRCR.net: The DRCR Network (DRCR.net) is a collaborative network dedicated to facilitating multicenter clinical research of diabetic retinopathy, age-related macular degeneration (AMD), hereditary retinal degenerations and other retinal diseases. The DRCR.net supports the identification, design, and implementation of multicenter clinical research initiatives focused on retinal disorders. Principal emphasis is placed on clinical trials, but epidemiologic outcomes and other research may be supported as well.
The DRCR.net was formed in September 2002 and currently includes over 115 participating sites (offices) with over 400 physicians throughout the United States. The DRCR.net is funded by the National Eye Institute (NEI). The NEI is a part of the National Institutes of Health, which is the branch of government that funds medical research.

Three core centers within the DRCR.net support overall operation and leadership of the network. The core centers are: the office of the Network Chairs (Jennifer K. Sun, M.D., M.P.H., Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts and Daniel F. Martin, M.D., Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio), the Coordinating Center (Director, Adam R. Glassman, M.S.; Executive Director, Roy W. Beck, M.D., Ph.D., Jaeb Center for Health Research, Tampa, FL), and the National Eye Institute (Project Officer, Sangeeta Bhargava, Ph.D.).

What are the possible serious side effects of the injection?

Possible serious side effects due to the injection itself include: (1) an increase in eye pressure, (2) the development of an infection in the eye, called endophthalmitis, which causes severe pain and needs prompt attention, (3) haziness in the lens of the eye, called cataract, (4) separation of the retina from the back of the eye (retinal detachment), and (5) bleeding in the eye. These can be serious but they are very uncommon. Common but less serious side effects of the injection which usually resolve in one to seven days include irritation of the eye, seeing floaters, and blood on the white part of the eye. Additional possible side effects due to the study drugs themselves include: (1) inflammation of the eye and (2) an allergic reaction. There may be a small increased risk of high blood pressure, heart attack, or stroke caused by Eylea®. These side effects occur when similar drugs are given in large doses into the vein to treat cancer. The dose being given in the eye is much smaller so we think that side effects to the body will be very rare if at all, but we cannot be sure at this time.

How long will the study last?

The study will last four years. Follow-up visits are at 1, 2, and 4 months and every 4 months thereafter. More frequent visits may be needed if you develop PDR or DME. What costs will be my responsibility? There may be charges for problems that might develop related to the treatments.

Will I be reimbursed for expenses?

If you take part in the study, you will be provided a $25 gift card for each required completed visit. If you do not complete all of the visits or discontinue the study before it ends, you will receive gift cards only for completed visits.

What do I need to do to participate in the study?

You will be given an Informed Consent Form to read. This document will provide much greater detail about the study. If you would like to consider being in the study, we will first ask you to sign the form so that testing can be done to determine if you likely meet all of the eligibility criteria for the study. It will require two separate visits within one month to determine if you are eligible. If you are eligible, we will again discuss the study and answer any questions you may have before you decide whether or not to enter the study.

Contact Us More Study Information

New patients interested in enrolling in this study, please send us an E-mail. Include your name, the reason of your interest in this study and the office location you receive treatment. You will receive a reply from us within 48 - 72 hours.

DRCR Protocol AC

North and South Region Patients

Intravitreous Aflibercept vs. Intravitreous Bevacizumab + Deferred Aflibercept for treatment of Central-Involved Diabetic Macular Edema

A multi-center study being conducted by the Diabetic Retinopathy Clinical Research Network sponsored by the National Institutes of Health, the U.S. Department of Health and Human Services.

General Information for a Patient Who May Want to Be a Participant in this Study

Your eye doctor is taking part in a study being conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net). This Network includes over 100 eye centers in the United States and Canada that specialize in the care of patients with diabetic eye disease.

The study is being funded by the National Eye Institute, which is a part of the National Institutes of Health, a branch of the U.S. Department of Health and Human Services that funds medical research.

Following we will tell you about diabetic macular edema and the treatments that are available as standard of care. Then we will explain what is involved if you want to be part of the study.

If you have diabetic macular edema and think you might be interested in taking part in the study, you will be given a document called an Informed Consent Form, which will provide a written explanation of the study in more detail. Your doctor and her/his staff will discuss the study with you and answer any questions you have. You will be given as much time as you may need to decide if you want to take part in the study.

What is Diabetic Macular Edema?

Diabetic Macular Edema (DME) is the term used for swelling in the small part of the retina used for central vision. This abnormal swelling is due to diabetic damage to the blood vessels. The retina is a thin layer of tissue that lines the back of your eye. It is nourished by blood vessels that may become affected by diabetes. The blood vessels are weekend by diabetes and may become leaky. This causes the retina to become thickened or swollen. Swelling of the central part of the retina can lead to decreased vision.

Interested in this study and ready to enroll?

Click Here

How is DME treated?

In most cases, repeated injections into the eye are given of a drug that blocks a substance called Vascular Endothelial Growth Factor ("anti-VEGF drug"). This is because abnormal levels of VEGF can be produced by a retina affected by diabetes. Anti-VEGF drugs decrease the growth of new blood vessels and prevent leakage of fluid from retinal blood vessels damaged by diabetes.

There are currently three different anti-VEGF drugs that are used as injections in eyes. However, only Avastin® and Eylea®, are being used in this study. A recent survey of eye doctors estimated about 60% of the injections in the U.S. for DME are given with Avastin®, about 25% of the injections given with Eylea®, and about 15% with a third anti-VEGF drug called Lucentis®.

Eylea® is approved by the FDA for DME treatment. Avastin® is approved by the FDA for the treatment of cancer. It is not approved for treating DME. It needs to be specially prepared for injecting in the eye.

Does one of the treatments work better?

Recently, a study was done by the DRCR.net comparing Avastin® and Eylea® for eyes with DME. The study showed that both drugs work very well to reduce DME and improve visual activity. However, when the starting vision was moderately or severly reduced (20/50 or worse), Eylea® was better on average than Avastin® at improving vision. Even though Eylea® was better on average, most people who received Avastin® still had very good results with improvements in vision from decreased swelling of the retina.

So why is Avastin® being used to treat DME more often than Eylea®?

Avastin® is much less expensive than Eylea®. Avastin® costs about $60 per injection compared with about $1,800 per injection Eylea®.

What is the purpose of this study?

The purpose of this study is to find out if starting with Eylea® has better results than starting with the less expensive drug, Avastin®, and only switching to Eylea® if needed.

What treatment will I receive if I take part in the study?

If you take part in the study, your treatment will be determined by chance. This is like flipping a coin to decide which treatment approach you will receive. You will receive either:
1) Eylea® injections from the start OR
2) Avastin® injections to start and switching to Eylea® injections only if needed.

What is involved with injections in the eye?

The injections are done through the white part of the eye with a needle which is about the size of a single hair. Before the injection is given, the surface of the white part of the eye is cleaned to prevent infection. Numbing medicine also is administered before the injection to numb the white part of the eye to minimize or eliminate any discomfort from the injection. When the injection is given, you typically will feel slight pressure but this is usually not very painful because of the tiny size of the needle used. After the injection, you may have slight discomfort for a few days.

What are the possible serious side effects of the injections?

Possible serious side effects due to the injection itself include:
1) an increase in eye pressure,
2) the development of an infection in the eye, called endophthalmitis, which causes severe pain and needs prompt attention,
3) haziness in the lens of the eye, called cataract,
or 4) separation of the retina from the back of the eye (retinal detachment).

These can be serious but they are very uncommon. Common but less serious side effects of the injection which usually resolve in one to seven days include irritation of the eye, seeing floaters, and blood on white part of the eye.

Additional possible side effects due to Eylea® or Avastin® itself include: inflammation of the eye or an allergic reaction. There may be an increased risk of high blood pressure, heart attack, or stroke due to these drugs. These side effects occur when similar drugs are given in large doses into the vein. The dose being given in the eye is much smaller so we think that side effects to the body will be very rare, but we cannot be sure.

How long will the study last?

The study will last two years. During that time, your visit, schedule and treatment will vary. During the first year, you will have follow-up visits every 4 weeks. During the second year, you will have follow-up visits every 4 weeks as long as you need monthly injections and then every 4 - 16 weeks once injections are stopped.

What costs will be my responsibility?

There may be charges for the treatments and office visits that would have been part of your regular eye care if you were not in the study. You and/or your insurance company will be responsible for these charges. There will be no out-of-pocket expenses to you for either the Avastin® or the Eylea®.

Will I be reimbursed for travel expenses?

If you take part in the study, you will be provided a $25 gift or money card for each required completed visit.

What do I need to do to participate in the study?

You will be given an Informed Consent Form to read. If you would like to consider being in the study, we will first ask you to sign that form so that testing can be done to determine if you meet all of the eligibility criteria for the study. If you are eligible, we will again discuss the study and answer any questions you may have before you decide whether or not to enter the study.

Contact Us More Study Information

New patients interested in enrolling in this study, please send us an E-mail. Include your name, the reason of your interest in this study and the office location you receive treatment. You will receive a reply from us within 48 - 72 hours.

Protocol GO29665

South Region Patients

Phase I/II, Open-Label, Dose-Escalation Study Of The Safety And Pharmacokinetics of Cobimetinib In Pediatric And Young Adult Patients With Previously Treated Solid Tumors.

Please find additional helpful information about this clinical trial at:

NIH U.S. National Library of Medicine, ClinicalTrials.gov - Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors (iMATRIXcobi) Summary: This open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult participants with solid tumors with known or potential kinase pathway activation for which standard therapy has proven to be ineffective or intolerable or for which no curative standard-of-care treatment options exist. The study will be conducted in two stages: a dose-escalation stage and an expansion stage at the recommended dose.

Orlando Health, Arnold Palmer Hospital for Children - Study of Safety & PK of Cobimetinib Pts w/Solid Tumors A Phase I/II, Multicenter, Open-Label, Dose-Escalation Study Of The Safety And Pharmacokinetics Of Cobimetinib In Pediatric And Young Adult Patients With Previously Treated Solid Tumors.

Protocol GO29665 is partnered with Orlando Health, Arnold Palmer Hospital for Health

This study is closed for enrollment but actively seeing current patients for 4 years-duration of study.

Protocol DRCR GEN-Genetics in Retinal Diseases

North Region Patients

Protocol GEN-Genes in Diabetic Retinopathy. General Information for a Patient Who May Want to Be a Participant in this study.

To better understand the effects of diabetes on the retina, the Diabetic Retinopathy Clinical Research Network (DRCR.net) is collecting a blood sample from people with diabetes. The blood sample will be used to extract DNA. DNA is the part of a cell that contains unique genetic information. It is hoped that through studies done on the DNA, scientists will develop a better understanding of how diabetes causes changes in the retina and how diabetic retinopathy can best be treated.

Scientists will be able to request the samples, DNA information, and/or other medical information that are available in this database for their research on diabetes, complications from diabetes, such as diabetic retinopathy, or other diseases. Each request will need to be approved by the Diabetic Retinopathy Clinical Research Network or a National Institutes of Health data access committee before the samples or information will be given to the scientists. If the request is approved, the scientist will be given the samples and the information that was collected about your diabetes, other medical conditions, treatments and eye exams. No information that can directly identify you will be given.

If you agree to be part of this study, we will collect one or two tubes of blood from you. Each tube will contain about 10 mL (about 2 teaspoons) of your blood. The blood sample will be sent to a central storage repository.

Contact Us More Study Information

New patients interested in enrolling in this study, please send us an E-mail. Include your name, the reason of your interest in this study and the office location you receive treatment. You will receive a reply from us within 48 - 72 hours.

Protocol GBV-102-002 (ALTISSIMO STUDY)

South Region Patients

An AMD treatment with fewer injections?

The ALTISSIMO clinical research study is evaluating an investigational drug that could potentially be administered to wet AMD patients as an injection every 6 months. The study will compare this investigational product to a current standard of care treatment injected every 2 months.

What is the ALTISSIMO study?

The ALTISSIMO clinical research study is evaluating the safety and effectiveness of an investigational drug in people living with neovascular (wet) age-related macular degeneration (AMD). In this study, the investigational drug will be compared to a drug currently used for treating wet AMD.

Can I leave the study after I start?

Participation is completely voluntary, and you may leave the study at any time, for any reason. Leaving the study will not affect the care you receive outside the study. The study doctor can discuss other treatment options with you.

How long will I be in the study?

Study participation is expected to last up to approximately 13 months and include about 15 visits to the study center.

What will happen if I join the study?

1) Written Consent.
You will need to read and sign a study consent form. You can ask as many questions as you want before signing. It is important that you fully understand what will happen during the study.

2) Screening Period.
The study doctor and staff will conduct tests to assess your qualifications for study participation. You will also be asked about your medical history, previous AMD treatments, medications you have taken, and other issues that may affect your ability to participate in the study.

3) Treatment Period.
After screening, if you qualify and choose to enroll, you will return for scheduled study visits over the next year. At some visits, you will be administered your assigned study drug. At all visits, you will undergo safety, clinical, and imaging assessments. Study visits are required and help the study doctor monitor your health and well-being. Visits also give you a chance to ask questions.

What drug is being studied?

The drug being studied is not approved for uses other than research. It is an investigational drug designed to be administered as an injection into the eye. As an extended-release formulation, this drug may offer the potential for people living with wet AMD to have fewer injections than the current standard of care options.

Will I receive the investigational drug?

You will be assigned to one of four study groups at random (by chance, like flipping a coin). Three groups will receive the investigational drug, and the other will receive current standard of care (SOC) treatment for wet AMD. The sham procedure mimics the injections but does not penetrate the eye. The study is using a sham procedure so that neither patients nor a limited number of study team members who evaluate results know who is receiving which injections. This approach helps protect the quality of study results by avoiding potential biases.

Investigational Drug

Study Groups

180 people among three groups
Investigational drug on Day 1, then 6 months later
Sham procedure 4 times
Wet AMD SOC Group
40 people in a single group
SOC treatment on Day 1, then every 2 months
Who can participate in this study?
About 220 people will participate in the ALTISSIMO study. You may qualify to join the study if you:
Are at least 50 years of age
Have been diagnosed with wet AMD
Meet additional requirements as determined by a screening process

Contact Us More Study Information

New patients interested in enrolling in this study, please send us an E-mail. Include your name, the reason of your interest in this study and the office location you receive treatment. You will receive a reply from us within 48 - 72 hours.

Protocol #BI 1467335 (1386.12) ROBIN Study

South Region Patients

A Randomized, Double masked, Placebo-controlled exploratory study to evaluate tolerability, Pharmacodynamics and Pharmacokinetics of Orally Administered BI 1467335 for 12 weeks with a 12- week follow up period in patients with Non-Proliferative Diabetic Retinopathy without Center-Involved Diabetic Macular Edema (ROBIN Study).

Taking a wait-and-see approach to your Diabetic Retinopathy?

Waiting until diabetic retinopathy progresses could lead to eye diseases that cause vision loss. Learn more about the ROBIN research study of an oral investigational drug that may be an alternative to laser or injection treatments for diabetic retinopathy.

Whether you have type 1 or type 2 diabetes, you already know that high blood sugar can be bad for the nerves and organs in your body. And as you have learned, it can also affect your vision.

Over time, high blood sugar has damaged the blood vessels in the back of your eye, causing diabetic retinopathy. While you may not have noticed any symptoms, as the disease progresses, vision problems can occur. Currently, the standard treatment for diabetic retinopathy involves a wait-and-see approach.

Treatment usually doesn’t start until more significant vision problems start to occur.

Unfortunately, these treatments involve lasers or injections, and can either damage the retina or fail to slow the progression of the eye disease, leading to vision loss.As a result, there is a need for treatments that can slow or stop eye disease progression in the early stages, while being safer and easier to take. The ROBIN study is evaluating an investigational oral drug that could have the potential to slow or even reverse the progression of diabetic retinopathy.

In the ROBIN study, doctors want to compare the safety and effectiveness of the investigational oral drug to placebo, which looks like the investigational drug, but contains no active medication. The results of this study will help provide more information about the investigational oral drug, and whether it could one day be used to treat diabetic retinopathy.

Who is eligible to participate in the ROBIN study?

To pre-qualify for this study, you must:

Be 18 years of age or older
Have been diagnosed with type 1 or type 2 diabetes, AND non-proliferative diabetic retinopathy
Not have had diabetic retinopathy treatment with laser within 3 months, or intraocular injections of medication within 6 months
All study-related visits, tests, and drugs will be provided at no cost. In addition, reimbursement for study-related travel may be available.

What will happen during the ROBIN study?

If you are eligible and agree to participate, you will be randomly assigned (like the flip of a coin) to receive the investigational drug or placebo. You have an equal chance of receiving either study drug (investigational or placebo). To prevent opinions about the study drugs from affecting the study results, you, the study doctor, and the study staff will not know which study drug you are receiving. However, in the event of an emergency, that information can be provided. You will take your study drug once a day for 12 weeks. Your total study participation will last about 30 weeks, which includes screening for eligibility, the study drug dosing period, and a follow-up period. During the study, you will be asked to attend approximately 8 study center visits to evaluate your health.

What are the benefits and risk related to the ROBIN study?

As with any research study, there is no guarantee you will benefit from the ROBIN study. However, your participation may help provide some benefit to people with diabetic retinopathy in the future. It is also possible you could experience a side effect while in this study. Before you begin the study, the study staff will review a full list of risks and side effects with you. Because research studies can affect the health and safety of participants, you will be monitored during this study. The sponsor of the ROBIN study was required to design a protocol, which explains all study procedures in detail. An independent review board responsible for participant safety reviewed this protocol and requires that it be followed exactly.

If you agree to be part of this study, we will collect one or two tubes of blood from you. Each tube will contain about 10 mL (about 2 teaspoons) of your blood. The blood sample will be sent to a central storage repository.

Contact Us More Study Information

New patients interested in enrolling in this study, please send us an E-mail. Include your name, the reason of your interest in this study and the office location you receive treatment. You will receive a reply from us within 48 - 72 hours.

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