JNJ-18201887 LTE
Research type
Research Study
Full title
Long-term Extension Study for Participants with Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) in JNJ-81201887 Parent Clinical Studies
IRAS ID
1010481
Contact name
Elena Bolaños Cascales
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2022-500747-21
ISRCTN Number
ISRCTN11083692
Clinicaltrials.gov Identifier
Research summary
Age-related macular degeneration (AMD) is an eye disease that can lead to vision loss. It happens when aging causes the central part of the vision to become blurry or dark due to damage to a part of the eye called the macula.
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* which may help prevent further damage to the retina and preserve vision.
In this long-term extension (LTE) study, researchers want to learn about the long-term safety and explore how well participants can tolerate (tolerability) JNJ81201887, when given as an injection into the eye during parent clinical studies (81201887MDG2001, 81201887MDG1003).
* Protein that protects retina from damage caused by an essential part of body's natural immune response called the complement system.
Participants with GA who were enrolled and received treatment with JNJ-81201887 or sham* in the parent studies.
*An inactive procedure designed to mimic the active procedure.
No study intervention will be administered to the participants in this LTE study. Participants who were enrolled and treated with JNJ-81201887 or sham in the parent clinical studies will be enrolled and followed-up for safety in this LTE study.
Participants who received sham in the parent study (81201887MDG2001) may have the option to receive JNJ-81201887 as an open-label treatment* under a separate study and will be followed-up for 5 years from time of administration of JNJ-81201887 in parent clinical studies.
*Both researchers and participants knew about the drug or treatment being given.
Participants will undergo study assessments such as eye tests, eye imaging scans, physical examination, monitoring of side effects, questionnaires and blood tests. All side effects will be recorded till the study ends (up to approximately 5 years from time of administration of JNJ-81201887).REC name
London - West London & GTAC Research Ethics Committee
REC reference
24/LO/0580
Date of REC Opinion
7 Nov 2024
REC opinion
Further Information Favourable Opinion