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.