A long-term extension study of JNJ-81201887 (AAVCAGsCD59) parent studies in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD)
This study is a long-term follow-up for people who previously received a new gene therapy called JNJ-81201887, or a sham (dummy) treatment, in earlier clinical trials. The therapy is for Geographic Atrophy (GA), a serious eye condition linked to Age-related Macular Degeneration (AMD) that causes vision loss. Researchers want to understand the long-term safety of JNJ-81201887 and how well people tolerate it. While no new treatment is given to everyone in this particular study, those who received the sham treatment before might get the active therapy in a separate study. Participants will have eye tests, scans, blood tests, and check-ups for around five years to monitor their health.
At a glance
What is this study about?
This research is looking further into a new treatment for an eye condition called Geographic Atrophy (GA). GA is a severe form of Age-related Macular Degeneration (AMD), which is a common cause of vision loss as people get older. With GA, the central part of your vision can become blurry or dark because of damage to a vital part of your eye called the macula. This damage is permanent and can get worse over time.
The experimental treatment, called JNJ-81201887, is a gene therapy. Gene therapies work by introducing new genetic material into the body’s cells. In this case, it aims to help the cells in the eye produce more of a protective protein called CD59. Scientists believe that increasing this protein might help shield the retina (the light-sensitive tissue at the back of your eye) from further harm and, hopefully, help protect your eyesight.
This particular study is a long-term 'extension' of earlier studies. This means it's not starting fresh but is following up with people who have already taken part in the initial trials of JNJ-81201887. The main goal is to find out if the treatment is safe over many years and how well people tolerate it long-term. No new treatment doses will be given in this specific study, but researchers will keep a close eye on the health of participants who received the gene therapy or a dummy treatment in the past.
Key takeaways
- This is a follow-up study for people who previously participated in JNJ-81201887 trials for Geographic Atrophy.
- The main aim is to check the long-term safety and how well people tolerate the gene therapy.
- No new gene therapy will be given to participants directly in this specific study, but monitoring will continue.
- Regular eye checks, scans, and blood tests will take place over approximately five years.
- Participation helps future patients, though no direct benefit is guaranteed for you from this follow-up part of the study.
- You will not have to pay to participate, and reasonable travel costs will be reimbursed.
Who may be eligible?
To be part of this study, you must have already taken part in one of the earlier studies of JNJ-81201887 (known as 81201887MDG2001 or 81201887MDG1003). In those studies, you would have received either the JNJ-81201887 gene therapy or a sham (dummy) treatment.
This long-term study is for adults. If you meet the above requirement, there are no other specific health reasons that would prevent you from joining this follow-up study. You (or your legal representative, if needed) will also need to sign a consent form, which shows you understand and agree to participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Have I already taken part in an earlier study of JNJ-81201887 (trial 81201887MDG2001 or 81201887MDG1003)?
- Did I receive either the JNJ-81201887 treatment or the dummy (sham) treatment in that previous study?
- Am I an adult?
- Am I willing to sign a consent form to participate and understand the study requirements?
What does participation involve?
If you take part in this study, you won't be given any new study medication directly within this long-term follow-up. However, if you received the 'sham' (dummy) treatment in the earlier study, you might have the chance to receive the actual JNJ-81201887 treatment in a separate, new study. For those who received the active treatment previously, this study primarily involves monitoring.
You will have regular check-ups for about five years from when you first received the JNJ-81201887 treatment in the original studies. These check-ups will include various assessments such as eye tests, special eye scans, general physical exams, blood tests, and questionnaires about your health. Doctors will carefully record any side effects you experience throughout the entire study period.
Potential risks and benefits
Locations (1)
- -Approximate-, England
Common questions
What is Geographic Atrophy (GA)?
Geographic Atrophy is a severe eye condition linked to Age-related Macular Degeneration (AMD) that causes a permanent loss of central vision.
What is JNJ-81201887?
It's an experimental gene therapy designed to help eye cells produce a protective protein called CD59, which might help prevent further vision loss in GA.
Will I receive new treatment in this study?
No new treatment is given to everyone in this long-term follow-up. If you received a dummy treatment before, you might have the option for the actual therapy in a different study.
How long will this study last for me?
You will be followed up for approximately five years from when you received the JNJ-81201887 treatment in the initial studies.
Who is paying for this study?
The study is funded by Janssen-Cilag International N.V., a pharmaceutical company.
How to find out more
Lorraine Smith
Always speak to your GP or specialist before deciding to take part in a study.
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