PARASOL
Research type
Research Study
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)
IRAS ID
1006234
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2022-500746-16
Research summary
Age-related macular degeneration (AMD) is an eye disease that can lead to vision loss. It happens when aging causes damage to part of the eye that controls sharp, straight-ahead vision. Geographic atrophy (GA) is an advanced form of AMD that leads to progressive and permanent loss of vision. JNJ-81201887 is a gene therapy that increases the ability of the retina cells to make CD59 (protein that protects retina from damage caused by an essential part of body's natural immune response called the complement system), helping prevent further damage.
In this study, researchers want to see if JNJ-81201887 is effective in reducing the growth of GA lesions in the treated eye. Male and female participants 60 years or older. After screening, participants will be randomly assigned to one of the three groups and will receive treatment as an injection in the study eye on Day 4 as shown below:
1. Group A: Single low dose JNJ-81201887.
2. Group B: Single high dose of JNJ-81201887
3. Group C: Single sham procedure (a similar procedure that involves a syringe with no needle) will be performed .
In addition to JNJ-81201887, participants will receive oral prednisone for 20 days from Day 1 and single corticosteroid injection around the eye on Day 4 in the eye for prevention of eye inflammation in Group A and B. Participants in Group C will receive placebo matched to oral prednisone for 20 days and a sham corticosteroid injection around the eye similar to Group A and B from Day 1.
Participants will enter long term extension study after completion of the treatment to monitor for safety.
During the study, tests will be performed such as blood and eye tests (use of various tools to take images of the inside of the eye). Blood samples, eye fluid, and tears will be taken at multiple timepoints to understand how the body responds to treatment. All systemic and eye related side effects will be recorded until study ends (up to 2 years 7 months).REC name
London - West London & GTAC Research Ethics Committee
REC reference
23/LO/0166
Date of REC Opinion
5 Sep 2023
REC opinion
Further Information Favourable Opinion