A Phase II, Randomized, Double-Masked, Controlled, Dose Comparison Study of Cand5 for Intravitreal Injection for the Treatment of Subfoveal Choroidal Neovascularization Associated with Wet Age-Related Macular Degeneration
Study Summary
The University of Chicago and Dr. Seenu Hariprasad are conducting a study to look at the safety 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 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. These vessels may leak fluid, bleed, or lift up the retina causing the gradual loss in vision. The experimental drug is thought to be able to reverse the swelling as well as to block the formation and growth of new blood vessels in the eye.
Once your doctor has determined that you are eligible to participate in this study, you will be assigned in a randomized fashion (i.e., like flipping a coin) to one of three study groups: either higher dose of the experimental drug, middle dose, or lower dose of the experimental drug. Research subjects will receive two injections of the experimental drug, which will occur six weeks apart. You will be asked to visit the research clinic before and after injections take place for follow-up visits.
Participants are expected to be in the study for about two years and have 10 scheduled study visits.
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 and be willing to undergo all study screening and follow-up procedures
- 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: #14202B
