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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

Long-term Extension Study for Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) in JNJ-81201887 Parent Clinical Studies

A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) (NCT06635148) is a Phase 2 interventional studying Geographic Atrophy and Macular Degeneration, sponsored by Janssen Research & Development, LLC. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Geographic Atrophy and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 274 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Geographic Atrophy subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Participants who were enrolled and received treatment with JNJ-81201887 or sham in a parent clinical study (81201887MDG2001, 81201887MDG1003) - Females (women of childbearing potential), male participants, and partners of male participants will not be required to use contraception in this LTE study - Must sign an willing to sign a consent form form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. The ICF may be signed by an impartial witness and/or legally designated representative depending on national/local regulations Who Should NOT Join This Trial: - There are no exclusion criteria for this LTE study Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Participants who were enrolled and received treatment with JNJ-81201887 or sham in a parent clinical study (81201887MDG2001, 81201887MDG1003) * Females (women of childbearing potential), male participants, and partners of male participants will not be required to use contraception in this LTE study * Must sign an informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. The ICF may be signed by an impartial witness and/or legally designated representative depending on national/local regulations Exclusion Criteria: * There are no exclusion criteria for this LTE study

Treatments Being Tested

DRUG

JNJ-81201887

No study intervention will be administered as part of this LTE study.

OTHER

Sham Procedure

No study intervention will be administered as part of this LTE study.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Retina Associates Southwest PC
Tucson, Arizona, United States
Retina Consultants of Orange County
Fullerton, California, United States
Shiley Eye Institute Jacobs Retina Center
La Jolla, California, United States
California Retina Consultants
Oxnard, California, United States
California Eye Medical Specialists
Pasadena, California, United States
Retina Consultants San Diego
Poway, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
VitreoRetinal Associates, PA
Gainesville, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
Georgia Retina
Marietta, Georgia, United States
Marietta Eye Clinic
Marietta, Georgia, United States
University Retina
Lemont, Illinois, United States
Midwest Eye Institute
Carmel, Indiana, United States
Maine Eye Center
Portland, Maine, United States
Retina Specialists
Baltimore, Maryland, United States
The Retina Group of Washington
Chevy Chase, Maryland, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06635148), the sponsor (Janssen Research & Development, LLC), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06635148 clinical trial studying?

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06635148?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06635148?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06635148. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06635148. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.