Parasol - 81201887MDG2001 (Age-Related Macular Degeneration) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Who Can Participate in the Study?

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.

Age Group
Adults

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.

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
Protocol Number
IRB: PRO00112430
NCT: NCT05811351
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment