CERA

Science and Research

Parasol: 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)

The Parasol trial is testing a new potential treatment for Geographic Atrophy, the hallmark sign of advanced dry age-related macular degeneration.

Overview

The Parasol trial is testing a new potential treatment for Geographic Atrophy, the hallmark sign of advanced dry age-related macular degeneration.

The drug being investigated in this study is a gene therapy vector called JNJ-81201887. Gene therapy is based on technology that may treat or cure disease by replacing, adding, or turning off a gene or protein in the cells.

JNJ-81201887 is being studied to learn more about how it can slow the progression of geographic atrophy by increasing the amount of a certain anti-inflammatory protein, called soluble clusters of differentiation 59 (CD59), that normally exist in your eye.
JNJ-81201887 will be administered via one single eye (intravitreal) injection.

As part of the study, suitable participants will be screened to determine their eligibility for the trial. If eligible, participants will be randomized into 1 of 3 groups.

Group 1 will receive a low dose of the actual study drug, Group 2 will receive a high dose of the study drug and group 3 will receive a sham (fake) injection. Participants must also take 20 days of anti-inflammatory capsules (oral steroids), or matching placebo tablets, depending on their randomisation.

In addition to the study injection, participants will also receive a steroid injection to the eye (except those in the sham group who will receive a sham procedure).

This study will run for 19 months and would require participants to attend our site in East Melbourne for 14 visits over this time frame. To note, 3 of these visits will occur within the first week of the trial once eligibility is confirmed.

For further information about this study please contact the Clinical Trials Research Centre on (03) 99298076 or email trials@cera.org.au.

  • Principal Investigator
Professor Robyn Guymer AM

Learn more

View this study on ClinicalTrials.gov

See the ClinicalTrials.gov database listing for more detailed information about this study.