A Phase 3 Study of Experimental Drug for Injection for the Treatment of Subfoveal Choroidal Neovascularization Associated with Age-Related Macular Degeneration
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 for subjects with "wet" or neovascular age-related macular degeneration (AMD). 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).
AMD is a common disease in people over 50 years of age, and in some patients it causes a gradual loss of vision. The "wet" or neovascular age-related macular degeneration (AMD) is caused by the growth of abnormal, diseased blood vessels in the back of the eye called CNV. These new blood vessels have fragile walls and can leak fluid into the retina, distorting vision or causing vision loss. The new blood vessels can also be the source of bleeding into the eye, which can cause severe and permanent visual loss. The experimental drug is thought to interrupt and reverse growth of these abnormal blood vessels in the back of the eye.
There will be 30 planned visits in this two-year study. If you qualify and agree to participate, you will be assigned randomly by chance (similar to tossing a coin) to one of three groups. You will receive one of the following: a higher dose of the study drug; a lower dose of the study drug; or a pretend infusion. The study drug will be given by an intravenous infusion that is given slowly (over 40 minutes) through a needle inserted in a vein in your arm, wrist, or the back of your hand. If you are assigned to receive a "placebo," such infusion will imitate the conditions of a true procedure, but does not use the active drug and has no effect. There is a 20 percent chance that you will receive "placebo." There is an 80 percent chance that you will receive the study drug.
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.
The progression of certain types of AMD may be slowed by photodynamic laser therapy (a procedure that uses cold laser with an intravenous light sensitive drug), which is allowed during this clinical study in addition to your assigned study therapy.
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)
- 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: #14068B
