Recruiting

Phase 2

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

Sponsor:

Janssen Research & Development, LLC

Code:

NCT06635148

Conditions

Geographic Atrophy

Macular Degeneration

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

JNJ-81201887

Sham Procedure

Study Details

Brief summary:

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.

Conditions

Geographic Atrophy

Macular Degeneration

Study ID

NCT06635148

Start date

Sep 19, 2024

Status verified date

Jul, 2026

Completion date

Jul 16, 2030

Anticipated

Primary completion date

Aug 24, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

274 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: JNJ-81201887 Low Dose

Study participants who were enrolled and received treatment with low dose JNJ-81201887 in parent clinical studies (81201887MDG2001 \[NCT05811351\]; 81201887MDG1003) will enter this long-term extension (LTE) study. No study intervention will be administered as part of this study.

experimental: Arm B: JNJ-81201887 High dose

Study participants who were enrolled and received treatment with high dose JNJ-81201887 in parent clinical studies (81201887MDG2001 \[NCT05811351\]; 81201887MDG1003) will enter this LTE study. No study intervention will be administered as part of this study.

sham comparator: Arm C: Sham Procedure

Participants randomized to the sham arm in parent study 81201887MDG2001 (NCT05811351) may have the option to receive JNJ-81201887 open-label treatment under a separate protocol after unmasking of that study; and will enter this LTE study. No intervention will be administered as part of this study.

Interventions

JNJ-81201887

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

Sham Procedure

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

Primary outcome measure

Number of Participants with Ocular and Systemic Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Upto 5 Years ]
Number of Participants with Abnormal Findings in Clinical Laboratory Assessments [ Time Frame: Upto 5 Years ]
Number of Participants with Abnormal Findings in Retinal imaging and Eye Examinations [ Time Frame: Upto 5 Years ]

Central Contacts and Locations

Central contacts

Study Contact

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

Locations

Retina Associates Southwest PC

Recruiting

Tucson, Arizona, United States, 85704

Retina Consultants of Orange County

Recruiting

Fullerton, California, United States, 92835

Shiley Eye Institute Jacobs Retina Center

Recruiting

La Jolla, California, United States, 92093 0946

California Retina Consultants

Recruiting

Oxnard, California, United States, 93036

California Eye Medical Specialists

Recruiting

Pasadena, California, United States, 91107

Retina Consultants San Diego

Recruiting

Poway, California, United States, 92064

Bay Area Retina Associates

Recruiting

Walnut Creek, California, United States, 94598

Retina Group of Florida

Recruiting

Fort Lauderdale, Florida, United States, 33308

VitreoRetinal Associates, PA

Recruiting

Gainesville, Florida, United States, 32607

Retina Specialty Institute

Recruiting

Pensacola, Florida, United States, 32503

Retina Vitreous Associates of Florida

Recruiting

St. Petersburg, Florida, United States, 33711

Georgia Retina

Recruiting

Marietta, Georgia, United States, 30060

Marietta Eye Clinic

Recruiting

Marietta, Georgia, United States, 30060

University Retina

Recruiting

Lemont, Illinois, United States, 60439

Midwest Eye Institute

Recruiting

Carmel, Indiana, United States, 46032

Maine Eye Center

Recruiting

Portland, Maine, United States, 04101

Retina Specialists

Recruiting

Baltimore, Maryland, United States, 21204

The Retina Group of Washington

Recruiting

Chevy Chase, Maryland, United States, 20815

Cumberland Valley Retina Consultants

Recruiting

Hagerstown, Maryland, United States, 21740

Ophthalmic Consultants of Boston

Recruiting

Boston, Massachusetts, United States, 02114

Foundation for Vision Research

Recruiting

Grand Rapids, Michigan, United States, 49546

Retina Consultants of Minnesota

Recruiting

Saint Louis Park, Minnesota, United States, 55416

The Retina Institute

Recruiting

St Louis, Missouri, United States, 63128

Sierra Eye Associates

Recruiting

Reno, Nevada, United States, 89502

Retina-Vitreous Surgeons of Central New York

Recruiting

Liverpool, New York, United States, 13088

Asheville Eye Associates - Western Carolina Retinal Associates

Recruiting

Asheville, North Carolina, United States, 28803

Duke Eye Center

Recruiting

Durham, North Carolina, United States, 27705

Graystone Eye

Recruiting

Hickory, North Carolina, United States, 28602

NC Retina Associates

Recruiting

Wake Forest, North Carolina, United States, 27587

Cincinnati Eye Institute

Recruiting

Cincinnati, Ohio, United States, 45242

Cleveland Clinic Main Campus

Recruiting

Cleveland, Ohio, United States, 44195

Verum Research LLC

Recruiting

Eugene, Oregon, United States, 97401

Cascade Medical Research Institute, LLC

Recruiting

Springfield, Oregon, United States, 97477

Erie Retina Research

Recruiting

Erie, Pennsylvania, United States, 16505

Charleston Neuroscience Institute, LLC

Recruiting

Beaufort, South Carolina, United States, 29902

Austin Clinical Research

Recruiting

Austin, Texas, United States, 78750

Texas Retina Associates

Recruiting

Dallas, Texas, United States, 75231

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Retina Associates Of South Texas P A

Recruiting

San Antonio, Texas, United States, 78240

Retina Consultants of Texas

Recruiting

The Woodlands, Texas, United States, 77384

Strategic Clinical Research Group

Recruiting

Willow Park, Texas, United States, 76087

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Piedmont Eye Center

Recruiting

Lynchburg, Virginia, United States, 24502

Wagner Kapoor Research institute

Recruiting

Norfolk, Virginia, United States, 23502

Spokane Eye Clinical Research

Recruiting

Spokane, Washington, United States, 99204

Alberta Retina Consultants

Recruiting

Edmonton, Alberta, Canada, T5H 0X5

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-07-06.