An Evaluation of Efficacy and Safety of Posterior Juxtascleral Administration of an Experimental drug in Patients at Risk for Developing Sight-Threatening Choroidal Neovascularization (CNV) Due to Age-Related Macular Degeneration (AMD)
Study Summary
The University of Chicago and Seenu Hariprasad, MD are conducting a study to look at the safety and effectiveness of an experimental drug in stopping the progression of the "dry" or early form of age-related macular degeneration (AMD) without choroidal neovascularization (CNV) to the "wet" or advanced form of AMD with CNV. 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.
Dr. Hariprasad invites you to participate in a research study if you have been diagnosed by your doctor as having an eye condition known as choroidal neovascularization (CNV) as a result of having a condition known as "wet" or advanced age-related macular degeneration (AMD) in one of your eyes, and the "dry" or early form of AMD without CNV in the other eye. AMD is a common disease in people over 55 years of age, and in some patients it causes a gradual loss of vision. CNV is the growth of new, abnormal blood vessels under the retina, which appears following the progression from "dry" to "wet" AMD. These vessels may leak fluid, bleed or lift up the retina causing the gradual loss in vision. Patients with "wet" AMD in one eye and "dry" AMD in the second eye are at significantly increased risk for the development of "wet" AMD in the second eye within 5 years.
If Dr. Hariprasad determines that you are eligible for the study and agree you to participate, you will be randomly assigned (by chance, similar to tossing a coin) to one of 3 groups. One group will receive an experimental drug of 15 mg, another group will receive 30 mg of an experimental drug, and a third group will not receive an experimental drug. The experimental drug will be administered behind the eye with a special curved instrument called a cannula that was designed for the procedure in this study. The procedure is called posterior juxtascleral administration. After the initial procedure, the injection will be repeated once every 6 months. The group of participants who were assigned not to receive an experimental drug will also undergo a pretend (also called "sham") injection.
Participants are expected to be in the study for about 4 years and have 8 scheduled study visits (once every 6 months).
You may receive no benefit from participating in this study. It is possible that the experimental drug may prevent the growth of abnormal blood vessels below your retina and help slow down vision loss in the treated eye. You will also have the knowledge that the results from this study may contribute to better treatment methods for patients with AMD like yourself.
Participation Details
To be considered for enrollment into the study, you must:
- Be at least 50 years of age
- Give written informed consent
- Have choroidal neovascularization (CNV) as a result of having a condition known as "wet" or advanced age-related macular degeneration (AMD) in one of your eyes, and the "dry" or early form of AMD without CNV in the other eye
- 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# 13429B
