Enrolling New Patients

This study is currently enrolling new patients.

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

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 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.

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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.

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.

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. 2) Protocol GO29665, partnered with Arnold Palmer Hospital for Children-Pediatrics Oncology Research

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.

Our Research Team

DRCR Protocol W

Dianelis: VA, assist Dr. in procedures

Lora, Francisco, Melvin, Cristal: OCT

Chanell: FA/FP

Ramona: Blood draw, back-up coordinator

Sasha: Dr.’s scribe

Elaine: Entering live data, HbA1C, urine lab, sending labs, regulatory paper work and keeping binder up to date, completing queries, assisting in site evaluations, making appointments for patients