Ask us about vitreoretinal diseases clinical trials and research studies.
Our research departments at Florida Retina Institute offer a comprehensive, most innovative list of clinical trials we particpate in, and onsite, in-house clinical research programs to all our patients.
A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients with Diabetic Macular Edema.
What is the purpose of the Photon Study?
Researchers are studying a high-dose Aflibercept (HD) at intervals of 12 and 16 weeks provide non-inferior best-corrected visual acuity (BCVA), anatomic and other visual measure response, safety, immunogenicity and pharmacokinetics (PK) of HD compared to 2 mg Aflibercept dosed every 8 weeks (already widely used by doctors to treat DME).
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).
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.
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.
Central Florida and North Florida 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.
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.
A12-Month, 2 Arm, Randomized, Double-Masked, Multicenter Phase III Study Assessing the Efficacy and Safety of Brolucizumab every 4 weeks versus Aflibercept every 4 weeks in Adult Patients with Visual Impairment due Diabetic Macular Edema.
What is the purpose of the Kingfisher Study?
Researchers are studying an investigational drug called Brolucizumab to see how safe and effective it is in treating patients with DME. They will do this by comparing it to another drug, Aflibercept, already widely used by doctors to treat DME.
Randomized Clinical Trial Assessing the effects of Pneumatic Vitreolysis on Vitroemacular Traction (Protocol AG)
Central Florida Patients
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.
Primary Objective: To compare the proportion of eyes with foveal VMT (symptomatic VMA) release on OCT after PVL with gas injection vs. observation (sham injection) in eye with VMT with-out an associated macular hole.
Secondary Objective: To evaluate visual function outcomes at 24 weeks after gas injection is performed compared with observation.
There will be two groups: PVL (injection of C3F8 gas) and Observation (Sham Injection).
Time in study 24 wks and patients will be using myVisionTrack. A password will be provided to all patients to use the myVisionTrack app with the patients' own password on phones and tablets at home.
There is rescue therapy of a Vitrectomy.
Optional Aqueous Sample collection and consent.
Single-Arm Study Assessing the Effects of Pneumatic Vitreolysis on Macular Hole (Protocol AH)
Central Florida Patients
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.Objective: To obtain estimates for the proportion of eye with macular hole closure of the inner retinal layers for eye with VMT and full-thickness macular holes treated with PVL.
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.
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.
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).
PROMINENT-Eye Evaluating the Effect of PEMAFIBRATE on Diabetic Retinopathy. This study is completed. The PROMINENT-Eye study was a part of the main PROMINENT study. It included about 900 adults who are randomized in the PROMINENT study in the USA and Canada. The purpose of the PROMINENT-Eye study was to show if pemafibrate can help reduce the worsening of diabetic retinopathy. A medication similar to pemafibrate has shown that this is possible if the same can be proven with pemafibrate, then this new treatment could be used to help reduce the loss of vision among patients with diabetes worldwide.
This study is completed. Clearside Biomedical, Inc. (NASDAQ:CLSD), a late-stage biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases, announced the enrollment of the first patient in a Phase 3 clinical trial (“TOPAZ”) of suprachoroidal CLS-TA used with an intravitreally administered anti-VEGF agent (“intravitreal anti-VEGF agent”) for the treatment of macular edema associated with Retinal Vein Occlusion (“RVO”). Suprachoroidal CLS-TA is Clearside’s proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye via the suprachoroidal space, or SCS™, which is the space located between the choroid and the outer protective layer of the eye known as the sclera.
Safety and Efficacy in patients with Neovascular Age-Related Macular Degeneration
0.2% twice daily in subjects with Neovascular Age-Related Macular Degeneration
Phase II study met primary endpoint, demonstrating promising visual acuity gains in patients with neovascular (wet) age-related macular degeneration.
Data shows the potential for less frequent dosing and reduced treatment burden with RTH258 compared to aflibercept.
Phase III clinical trial program initiated in December 2014, with 1700 patients expected to be enrolled in more than 50 countries.
Basel, February 27, 2015 - Alcon, the global leader in eye care, presented positive results from its second Phase II clinical study of RTH258 during the 38th Annual Macula Society Meeting in Scottsdale, Arizona. This study evaluated the efficacy and safety of the compound versus aflibercept in patients with neovascular (wet) age-related macular degeneration (AMD). RTH258 (formerly known as ESBA1008) is a novel, single-chain antibody fragment developed to treat wet AMD.
The Phase II study met its primary endpoint, demonstrating promising visual acuity gains that were non-inferior to aflibercept, with numerically greater reduction and rapid improvement in abnormal retinal fluid observed in RTH258-treated patients. Patients treated every three months with RTH258 also experienced a prolonged duration-of-action, potentially leading to a reduced treatment burden. A total of 90 patients diagnosed with wet AMD participated in the prospective, randomized, double-masked multicenter, two-arm study. The primary objective was to compare the efficacy of RTH258 6mg versus aflibercept 2mg with the primary endpoint being the mean change in best corrected visual acuity (BCVA), from Baseline to Week 12. Secondary endpoints included the change assessment in BCVA and central subfield foveal thickness (CSFT) as measured by spectral domain optical coherence tomography (SD-OCT). Both RTH258 and aflibercept were well tolerated and no new safety signal was reported during the study.
"Alcon is deeply committed to addressing unmet patient needs in retina, and RTH258 demonstrates the potential to improve visual outcomes and reduce the treatment burden for patients with wet AMD," said Sabri Markabi, Senior Vice President, Research & Development for Alcon. "We have initiated our Phase III study program based on the encouraging results we received from the Phase II studies with RTH258."
With these positive Phase II results, Alcon has initiated its Phase III clinical study program to evaluate the efficacy and safety of RTH258 versus aflibercept in patients with wet AMD. As part this innovative study program, Alcon expects to enroll approximately 1,700 patients in more than 50 countries worldwide. The primary objective of the first Phase III study is to compare the efficacy of RTH258 3mg and 6mg versus aflibercept 2mg, with the mean change in BCVA, from Baseline to Week 48 as the primary endpoint. The second study within the Phase III trial program will also compare the efficacy of RTH258 versus aflibercept, and is expected to commence in 2015. Patients participating in the Phase III studies will be dosed every three months with RTH258, while a bi-monthly-dosing regimen will be followed for those patients considered unsuitable for a quarterly dosing schedule due to disease activity. Aflibercept will be dosed according to its approved label. Please visit www.clinicaltrials.gov (link is external) for further details about the RTH258 Phase III clinical trial program.
AMD is a leading cause of severe vision loss in people over age 50,, and the United Nations estimates that it impacts 25 to 30 million people worldwide. AMD occurs when the center of the retina, known as the macula, deteriorates leading to gradual loss in central vision.
The foregoing release contains forward-looking statements that can be identified by words such as "potential," "expected," "promising," "potentially," "committed," "encouraging," "to evaluate," "expects," "will," or similar terms, or by express or implied discussions regarding potential marketing approvals for RTH258, or regarding potential future revenues from RTH258. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that RTH258 will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that RTH258 will be commercially successful in the future. In particular, management's expectations regarding RTH258 could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and over-the-counter products. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 130,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.
Juvenile Diabetes Research Foundation funded Phase II Clinical Trial, The iDEAL Study, iCo Therapeutics,www.iDEALStudy.org
FDA Phase II Clinical Trials - Ranibizumab (Lucentis) in the Treatment of Macular Degeneration, Sea Horizon Study, Genentech
FDA Phase IIIB Extension Study - Ranibizumab (Lucentis) in the treatment of Choroidal Neovascularization secondary to Age-Related Macular Degeneration, Genentech
FDA Phase III Clinical Trials - Posurdex in the treatment of Retinal Vascular Occlusive Disease, Allergan
FDA Phase II Clinical Trials - Rhufab in Macular Degeneration, Genentech Corporation, Anchor Study
FDA Phase II Clinical Trials - Rhufab in Macular Degeneration, Genentech Corporation, Marina Study
CMV Retinitis and Viral Resistance Study: Sub-Investigator. Bascom Palmer Eye Institute, Miami, Florida
FDA Phase III Clinical Trials - Visudyne (Verteporfin) in the Treatment of Age Related Macular Degeneration, Johns Hopkins University
For more information about clinical trials or if you should have any questions, please feel free to contact us.