Phase 2 Trial of an Experimental Drug in Subjects with recent vision loss due to Macular Edema Following Central Retinal Vein Occlusion

Study Summary

The University of Chicago and Dr. Seenu Hariprasad are conducting a study to look at the safety and effectiveness of an experimental drug. You are eligible to participate in a research study if you have been diagnosed as having macular edema (swelling of the macula) due to central retinal vein occlusion within the last 6 months and have poor vision as a result of this condition. The macula is a small and highly sensitive part of the retina and is essential for detailed vision, such as reading. The retina is the light-sensitive tissue at the back of your eye. Macular edema due to central retinal vein occlusion is caused by the blockage of one of the veins that drain blood out of the retina back to the heart.

The study drug has recently been approved by the Food and Drug Administration (FDA) for treatment of macular degeneration, but not for the indication that in being studied in this trial. It is thought that the study drug may slow the growth of abnormal blood vessels as well as reduce swelling in the eye. The purpose of this study is to compare the safety and efficacy of an injection containing the study drug to a “pretend” injection. In addition, the purpose of this study is to measure the action of an experimental drug in the body over a period of time and to check for the presence of the study drug in your blood (called pharmacokinetics or PK).

If you qualify and agree to participate, you will be assigned randomly by chance (similar to tossing a coin) to one of 3 procedures. You will receive one of the following: a higher dose of the study drug; a lower dose of the study drug; or a pretend procedure. Injection containing the study drug OR pretend injection will occur every 6 weeks as long as you are benefiting from the study.

You are expected to be in the study for about 54 weeks. There will be up to 24 visits. You will be not paid for participation on this study. You may receive no benefit from participating in this study. However, knowledge gained from this study may help in the future treatment of people with macular edema.

Participation Details

To be considered for enrollment into the study, you must:

• Be at least 18 years of age
• Give written informed consent
• Have macular edema due to central retinal vein occlusion diagnosis within the last 6 months
• Be willing to undergo a study drug injection or undergo a pretend procedure which simulates an actual injection
• Be available for study visits for the duration of the study
• Not be pregnant or breastfeeding during the study
• Meet study eligibility criteria as evaluated by Dr. Hariprasad
• Understand the study instructions and be able to follow the study instructions

Study Director: Seenu Hariprasad, MD
Department: Ophthalmology

For more information contact:
Sophie Gen, CCRP
sgen@bsd.uchicago.edu
(773) 702-7666

IRB: #13121B