Purpose of this Study
If you choose to join the study, you will:
- Get a random assignment (like drawing numbers from a hat) to receive in the eye one injection of one of two dose levels (low or high dose) of the study drug or placebo (inactive substance)
- Be in touch with the study team for about 19 months
- Visit our clinic at the Duke Eye Center up to 13 times
At various visits, you will have blood tests, answer questionnaires, and have eye exams and vision tests.
- Get a random assignment (like drawing numbers from a hat) to receive in the eye one injection of one of two dose levels (low or high dose) of the study drug or placebo (inactive substance)
- Be in touch with the study team for about 19 months
- Visit our clinic at the Duke Eye Center up to 13 times
At various visits, you will have blood tests, answer questionnaires, and have eye exams and vision tests.
Who Can Participate?
Eligibility
Adults ages 60+ who:
- Are diagnosed with geographic atrophy secondary to age-related macular degeneration
- Have no history or presence of retinal disease other than GA
- Have no other ocular disease that might require surgery within 18 months or could affect the interpretation of test results
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.
- Are diagnosed with geographic atrophy secondary to age-related macular degeneration
- Have no history or presence of retinal disease other than GA
- Have no other ocular disease that might require surgery within 18 months or could affect the interpretation of test results
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.
Age Range
60-89
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
We are doing this study to find out if an experimental drug called JNJ-81201887 (the study drug) is a safe and effective option for patients with Geographic Atrophy secondary to Age-Related Macular Degeneration.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Principal Investigator
Eleonora
Lad
Protocol Number
PRO00112430
NCT ID
NCT05811351
Phase
II
Enrollment Status
OPEN TO ACCRUAL