RecruitingPHASE2INTERVENTIONAL

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 research is a continuation study, checking on people who previously took part in earlier studies testing a new treatment called JNJ-81201887 for geographic atrophy. Geographic atrophy is an advanced form of age-related macular degeneration that causes blind spots in your central vision. The main goal of this long-term study is to see how safe this treatment is over a longer period and how well people tolerate it, especially after receiving a direct injection into the eye. It's important to understand the long-term effects of any new medication. This study hopes to provide valuable information about the lasting safety of JNJ-81201887, helping us understand its potential to help people with this eye condition.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Janssen Research & Development, LLC

Enrolment target

274

Start

19 Sep 2024

Estimated completion

16 Jul 2030

Geographic Atrophy Macular Degeneration

What is this study about?

This research is a continued study for people who have geographic atrophy (GA), which is an advanced form of age-related macular degeneration (AMD). AMD is a common eye condition that affects the central part of your vision, which you use for things like reading and recognising faces. In GA, special cells in the retina (the light-sensitive layer at the back of your eye) waste away, creating blind spots.

In earlier studies, some volunteers received a new treatment called JNJ-81201887, which involves an injection into the eye. Other volunteers in those studies received a 'sham' procedure, which is like a dummy treatment used for comparison. This new long-term study will continue to follow up with participants from those earlier trials.

The main aim of this long-term study is to understand the safety of JNJ-81201887 over many years. It will also look at how well people tolerate the treatment. By carefully watching these participants, researchers hope to gather important information about the long-term effects, both positive and negative, of this potential new treatment for geographic atrophy.

Key takeaways

This is a long-term follow-up study for people who were in earlier trials.
It aims to check the safety and how well JNJ-81201887 is tolerated over time.
Participants must have previously received JNJ-81201887 or a 'sham' procedure.
The study focuses on geographic atrophy, a type of severe macular degeneration.
Participation involves ongoing monitoring of your eye health.

Who may be eligible?

To be able to join this particular long-term study, you must have already taken part in one of the earlier research studies for JNJ-81201887. In those previous studies, you would have either received the JNJ-81201887 treatment or a 'sham' procedure (a dummy treatment).

There are no additional strict rules that would stop you from joining this long-term study once you've been in one of the earlier ones. Anyone, male or female, who was part of the original studies and meets the other basic requirements can take part.

Before you can join, you will need to read and sign an 'informed consent form'. This form explains exactly what the study involves, so you understand everything before you agree to participate. You can be aged 60 or older.

Quick self-check

Did I participate in a previous study for JNJ-81201887?
Did I receive either the JNJ-81201887 treatment or a sham procedure in that earlier study?
Am I aged 60 or older?
Am I willing to read and sign an 'informed consent form'?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, it means you will continue to have regular check-ups with the study team. These check-ups will allow doctors to monitor your eye health and overall well-being. They will likely involve eye examinations and other tests to see how you are doing over time.

Since this is an extension study, you would have already received either the JNJ-81201887 treatment or a sham procedure in a previous study. You won't be receiving new treatment with JNJ-81201887 as part of this particular follow-up study. The total duration of this long-term follow-up will depend on the study plan, but it's designed to gather information for an extended period.

Potential risks and benefits

Taking part in a long-term study helps researchers understand how a treatment works and whether it’s safe over many years. This could benefit others with geographic atrophy in the future. However, there might be some small risks, such as discomfort during eye exams or the time commitment for appointments. All previous treatments have their own known risks, which you would have discussed in the original study. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (104)

Retina Associates Southwest PC
Tucson, United States· Recruiting
Retina Consultants of Orange County
Fullerton, United States· Recruiting
Shiley Eye Institute Jacobs Retina Center
La Jolla, United States· Recruiting
California Retina Consultants
Oxnard, United States· Recruiting
California Eye Medical Specialists
Pasadena, United States· Recruiting
Retina Consultants San Diego
Poway, United States· Recruiting
Bay Area Retina Associates
Walnut Creek, United States· Recruiting
Retina Group of Florida
Fort Lauderdale, United States· Recruiting
VitreoRetinal Associates, PA
Gainesville, United States· Recruiting
Retina Specialty Institute
Pensacola, United States· Recruiting
Retina Vitreous Associates of Florida
St. Petersburg, United States· Recruiting
Georgia Retina
Marietta, United States· Recruiting

+92 more sites — see the official record for the full list.

Common questions

What is geographic atrophy?

Geographic atrophy is a severe form of age-related macular degeneration (AMD) that causes blind spots in your central vision, making it harder to read or see fine details.

Who is eligible for this study?

Only people who have previously participated in specific earlier studies testing JNJ-81201887, whether they received the treatment or a dummy procedure, can join this long-term study.

Will I receive new treatment in this study?

No, this study is a follow-up. You would have already received treatment (or a dummy procedure) in a previous study. This study is about monitoring your long-term safety.

What is a 'sham procedure'?

A sham procedure is like a dummy treatment, often used in studies to compare against the real treatment and help researchers understand the true effect of the medication.

How long will this study last?

This is a long-term study to monitor participants over an extended period, but the exact duration will be explained by the study team.

How to find out more

Study Contact

Participate-In-This-Study1@its.jnj.com 844-434-4210 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.