A study to compare JNJ-81201887 to a sham procedure for the treatment of geographic atrophy secondary to age-related macular degeneration
Age-related macular degeneration (AMD) is a common eye condition that affects central vision. Geographic atrophy is an advanced stage of dry AMD that causes gradual, permanent vision loss as retinal cells die away. Currently, treatment options are limited. This study tests an experimental gene therapy called JNJ-81201887. It is designed to help eye cells produce a natural protective protein that shields the retina from damage caused by the body's immune system. Participants aged 60 and over will be randomly assigned to receive either a single injection of the study drug (at a low or high dose) or a dummy procedure with no needle. Participants will also take steroid medicine to help prevent eye inflammation. The study lasts about one year and seven months, with regular hospital visits to check your vision, monitor eye health, and assess safety.
En un coup d'œil
De quoi parle cette étude ?
Age-related macular degeneration, often called AMD, is a leading cause of vision problems in older adults. It affects the macula, which is the part of the eye responsible for sharp, detailed, central vision. Geographic atrophy is an advanced form of dry AMD. Over time, patches of cells in the retina waste away and stop working, creating blind spots that gradually make reading, driving, and recognising faces much harder.
At present, there are very few treatments that can stop this progressive sight loss. In people with geographic atrophy, a part of the body's immune system—known as the complement system—becomes overactive and mistakenly attacks healthy cells in the retina. Researchers have developed an experimental gene therapy, called JNJ-81201887, to try to protect these cells. The treatment delivers genetic instructions directly to the retina, encouraging it to produce a protein that acts like a shield against this immune attack.
This phase II trial aims to find out whether a single dose of this new gene therapy can safely slow down the growth of damaged patches in the eye. By comparing the treatment to a dummy procedure, doctors hope to gather clear evidence on whether this therapy works. If successful, it could offer a valuable way to help protect sight for people living with advanced AMD in the future.
Points clés
- Tests a new gene therapy designed to protect retinal cells and slow dry AMD vision loss.
- Compares a single active eye injection against a needle-free dummy procedure.
- Open to adults aged 60 and older with measurable geographic atrophy.
- Includes steroid medicine to help prevent inflammation in the eye.
- Lasts around 19 months with regular check-ups, and travel expenses are refunded.
Qui peut être éligible ?
This study is open to men and women aged 60 and older who have geographic atrophy caused by dry age-related macular degeneration. To qualify, the patches of eye damage must be a specific size, but they must not yet have reached the very centre of your vision (known as the fovea).
Your other eye must also have some useful sight remaining (at least enough vision to count fingers). Specialist eye scans taken during an initial screening visit will confirm whether your eyes meet the exact measurements required for the trial.
You may not be able to take part if you have had certain previous eye treatments, such as specific laser therapies or radiation therapy in the study eye. You must also be well enough to safely take the temporary steroid medicines used during the study.
Cet étude pourrait-elle vous convenir ?
Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.
- You are aged 60 or older.
- You have geographic atrophy caused by dry age-related macular degeneration (AMD).
- The very centre of your central vision is not yet completely affected.
- You have fair vision in your other eye (at least able to count fingers).
- You are able to travel to regular clinic appointments over roughly 19 months.
En quoi consiste la participation ?
Taking part in the trial lasts about one year and seven months (19 months), with the option to join a longer follow-up study afterwards. After initial screening checks, you will be randomly placed into one of three groups. Two groups receive the real gene therapy as a single injection into the eye (either a low or high dose). The third group receives a dummy 'sham' procedure, which uses a syringe without a needle to gently press against the eye so it feels similar without delivering any medicine.
To prevent swelling and inflammation, participants getting the gene therapy will also take steroid tablets for 20 days and receive a single steroid injection around the eye. Those in the dummy group will take dummy tablets and receive a dummy steroid procedure.
Throughout the study, you will attend regular clinic visits for eye checks, scans, vision tests, and blood samples. These tests help doctors monitor how your eyes and body respond. All study treatments and tests are provided free of charge, and reasonable travel and parking expenses will be reimbursed.
Risques et avantages potentiels
Locations (23)
- The Retina ClinicVille uniquementLondon, England
- Southampton University HospitalVille uniquementSouthampton, England
- Bristol Eye HospitalApproximatifBristol, England
- Hôpital Royal d'Ophtalmologie de ManchesterApproximatifManchester, England
- Moorfields Eye HospitalApproximatifLondon, England
- Oxford Eye HospitalNon vérifiéOxford, England
- Central Middlesex HospitalNon vérifiéLondon, England
- Adelaide Eye and Retina CentreNon vérifiéAdelaide, Australia
- Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart TilmanNon vérifiéLeige, Belgium
- Queen Elizabeth II - Health Sciences CentreNon vérifiéNova Scotia, Canada
- InselspitalNon vérifiéBern, Switzerland
- AXON Clinical s.r.o.Non vérifiéPrague, Czech Republic
Questions fréquentes
What is a sham procedure?
A sham procedure is a dummy treatment designed to feel like the real thing. A syringe without a needle is pressed gently against the eye, allowing researchers to make a fair comparison without participants knowing which group they are in.
Will I definitely receive the real gene therapy?
Not necessarily. A computer randomly decides which group you join. You will have a two-in-three chance of receiving the active gene therapy (at either a low or high dose) and a one-in-three chance of receiving the dummy procedure.
How is the treatment given?
The gene therapy is given as a single injection directly into the study eye on Day 4 of the study. Numbing drops or anaesthetic are used beforehand to keep you comfortable.
Do I have to pay to take part?
No. The study treatment, scans, and doctor visits are completely free. You will also be reimbursed for reasonable travel and parking expenses linked to your study visits.
What happens if I change my mind during the study?
Taking part is entirely your choice. You can withdraw from the study at any point without it affecting your standard eye care or your relationship with your healthcare team.
Comment en savoir plus
Lorraine Smith
Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.
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