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

June 4, 2026 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

274

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • East Melbourne, Australia, 3002
        • Recruiting
        • Centre For Eye Research Australia
      • Strathfield, Australia, 2135
        • Recruiting
        • Strathfield Retina Clinic
      • Sydney, Australia, 2000
        • Recruiting
        • Sydney Retina Clinic and Day Surgery
      • Westmead, Australia, 2145
        • Recruiting
        • Sydney West Retina
  • Belgium
      • Genk, Belgium, 3600
        • Active, not recruiting
        • Ziekenhuis Oost-Limburg
      • Ghent, Belgium, 9000
        • Active, not recruiting
        • UZ Gent
      • Leuven, Belgium, 3000
        • Active, not recruiting
        • UZ Leuven Gasthuisberg
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5H 0X5
        • Recruiting
        • Alberta Retina Consultants
  • China
      • Beijing, China, 100730
        • Recruiting
        • Beijing Tongren Hospital CMU
      • Chengdu, China, 610041
        • Recruiting
        • West China Hospital Si Chuan University
      • Shanghai, China, 200080
        • Recruiting
        • Shanghai General Hospital
  • Czechia
      • Prague, Czechia, 100 34
        • Recruiting
        • Fakultni nemocnice Kralovske Vinohrady
      • Prague, Czechia, 15000
        • Recruiting
        • Axon Clinical s.r.o.
  • Denmark
      • Glostrup Municipality, Denmark, 2600
        • Active, not recruiting
        • University Hospital Of Copenhagen, Glostrup Hospital
  • Germany
      • Bonn, Germany, 53127
        • Recruiting
        • Universitaets-Augenklinik Bonn
      • Göttingen, Germany, 37075
        • Recruiting
        • Klinikum Gottingen der Georg August Universitat
      • Hanover, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
      • Leipzig, Germany, 04103
        • Recruiting
        • Universitaetsklinikum Leipzig
      • Ludwigshafen am Rhein, Germany, 67063
        • Recruiting
        • Klinikum Ludwigshafen
      • Münster, Germany, 48145
        • Recruiting
        • Augenzentrum am St Franziskus Hospital Munster
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitaetsklinikum Tuebingen
  • Hungary
      • Budapest, Hungary, 1062
        • Recruiting
        • Eszak Pesti Centrumkorhaz Honvedkorhaz
      • Pécs, Hungary, 7621
        • Recruiting
        • Ganglion Orvosi Központ
      • Zalaegerszeg, Hungary, 8900
        • Recruiting
        • Zala Varmegyei Szent Rafael Korhaz
  • Italy
      • Ferrara, Italy, 44124
        • Recruiting
        • Azienda Ospedaliero Universitaria di Ferrara
      • Milan, Italy, 20132
        • Recruiting
        • Irccs Ospedale San Raffaele
      • Milan, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Milan, Italy, 20157
        • Recruiting
        • ASST Fatebenefratelli Sacco
      • Naples, Italy, 80138
        • Recruiting
        • Azienda Ospedaliero Universitaria Luigi Vanvitelli
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario A Gemelli IRCCS
  • Netherlands
      • Nijmegen, Netherlands, 6525 GA
        • Active, not recruiting
        • Radboudumc
      • Rotterdam, Netherlands, 3011
        • Active, not recruiting
        • Het Oogziekenhuis Rotterdam
  • Poland
      • Bydgoszcz, Poland, 85 631
        • Active, not recruiting
        • Oftalmika
      • Warsaw, Poland, 01 258
        • Active, not recruiting
        • Warszawski Szpital Okulistyczny
  • Portugal
      • Coimbra, Portugal, 3000 075
        • Active, not recruiting
        • Uls Coimbra - Hosp. Univ. Coimbra
      • Coimbra, Portugal, 3030 163
        • Active, not recruiting
        • Espaco Medico de Coimbra
      • Porto, Portugal, 4200 319
        • Recruiting
        • Uls Sao Joao
  • Spain
      • Barcelona, Spain, 08021
        • Recruiting
        • Centro de Oftalmologia Barraquer
      • Barcelona, Spain, 08022
        • Recruiting
        • Centro Medico Teknon S.L.
      • Barcelona, Spain, 08022
        • Recruiting
        • Inst. Cat. de Retina
      • Burjassot, Spain, 46100
        • Recruiting
        • Clinica Oftalvist Valencia
      • Córdoba, Spain, 14012
        • Recruiting
        • Hosp. La Arruzafa
      • Madrid, Spain, 28041
        • Recruiting
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spain, 28046
        • Recruiting
        • Clinica Baviera Madrid Castellana
      • Madrid, Spain, 28040
        • Recruiting
        • Hosp Univ Fund Jimenez Diaz
      • Majadahonda, Spain, 28222
        • Recruiting
        • Hosp. Univ. Pta. de Hierro Majadahonda
      • Pamplona, Spain, 31008
        • Recruiting
        • Clinica Univ. de Navarra
      • Sant Cugat del Vallès, Spain, 08195
        • Recruiting
        • Idc Salud Hosp. Gral. de Catalunya
      • Seville, Spain, 41013
        • Recruiting
        • Hosp. Virgen Del Rocio
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hosp. Clinico Univ. Lozano Blesa
  • Sweden
      • Stockholm, Sweden, 171 64
        • Active, not recruiting
        • S:t Eriks Ogonsjukhus
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital Universitatsspital Bern
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe University Medical Faculty
      • Ankara, Turkey (Türkiye), 06490
        • Recruiting
        • Baskent University Ankara Hospital
      • Izmir, Turkey (Türkiye), 35330
        • Recruiting
        • Dokuz Eylul University Medical Faculty
  • United Kingdom
      • Bristol, United Kingdom, BS1 2LX
        • Active, not recruiting
        • Bristol Eye Hospital
      • Headington, United Kingdom, OX3 9DU
        • Active, not recruiting
        • Oxford Eye Hospital
      • London, United Kingdom, W1G 9AX
        • Active, not recruiting
        • The Retina Clinic London
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Active, not recruiting
        • Royal Victoria Infirmary
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • Retina Associates Southwest PC
    • California
      • Fullerton, California, United States, 92835
        • Recruiting
        • Retina Consultants of Orange County
      • La Jolla, California, United States, 92093 0946
        • Recruiting
        • Shiley Eye Institute Jacobs Retina Center
      • Oxnard, California, United States, 93036
        • Recruiting
        • California Retina Consultants
      • Pasadena, California, United States, 91107
        • Recruiting
        • California Eye Medical Specialists
      • Poway, California, United States, 92064
        • Recruiting
        • Retina Consultants San Diego
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Bay Area Retina Associates
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Retina Group of Florida
      • Gainesville, Florida, United States, 32607
        • Recruiting
        • VitreoRetinal Associates, PA
      • Pensacola, Florida, United States, 32503
        • Recruiting
        • Retina Specialty Institute
      • St. Petersburg, Florida, United States, 33711
        • Recruiting
        • Retina Vitreous Associates of Florida
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Georgia Retina
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Marietta Eye Clinic
    • Illinois
      • Lemont, Illinois, United States, 60439
        • Recruiting
        • University Retina
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Recruiting
        • Midwest Eye Institute
    • Maine
      • Portland, Maine, United States, 04101
        • Recruiting
        • Maine Eye Center
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Recruiting
        • Retina Specialists
      • Chevy Chase, Maryland, United States, 20815
        • Recruiting
        • The Retina Group of Washington
      • Hagerstown, Maryland, United States, 21740
        • Recruiting
        • Cumberland Valley Retina Consultants
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Ophthalmic Consultants of Boston
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • Foundation for Vision Research
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Retina Consultants of Minnesota
    • Missouri
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • The Retina Institute
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Sierra Eye Associates
    • New York
      • Liverpool, New York, United States, 13088
        • Recruiting
        • Retina-Vitreous Surgeons of Central New York
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Recruiting
        • Asheville Eye Associates - Western Carolina Retinal Associates
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke Eye Center
      • Hickory, North Carolina, United States, 28602
        • Recruiting
        • Graystone Eye
      • Wake Forest, North Carolina, United States, 27587
        • Recruiting
        • NC Retina Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Cincinnati Eye Institute
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Main Campus
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Verum Research LLC
      • Springfield, Oregon, United States, 97477
        • Recruiting
        • Cascade Medical Research Institute, LLC
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16505
        • Recruiting
        • Erie Retina Research
    • South Carolina
      • Beaufort, South Carolina, United States, 29902
        • Recruiting
        • Charleston Neuroscience Institute, LLC
    • Texas
      • Austin, Texas, United States, 78750
        • Recruiting
        • Austin Clinical Research
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Texas Retina Associates
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Retina Associates Of South Texas P A
      • The Woodlands, Texas, United States, 77384
        • Recruiting
        • Retina Consultants of Texas
      • Willow Park, Texas, United States, 76087
        • Recruiting
        • Strategic Clinical Research Group
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Recruiting
        • Piedmont Eye Center
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Wagner Kapoor Research institute
    • Washington
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Spokane Eye Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: JNJ-81201887
No study intervention will be administered as part of this LTE 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.
Drug: JNJ-81201887
No study intervention will be administered as part of this LTE 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.
Other: Sham Procedure
No study intervention will be administered as part of this LTE study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Ocular and Systemic Treatment-emergent Adverse Events (TEAEs)
Time Frame: Upto 5 Years
Number of participants with ocular and systemic TEAEs will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as any adverse event occurring at or after the administration of study intervention.
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 clinical laboratory Assessments (including hematology and clinical chemistry) will be reported.
Upto 5 Years
Number of Participants with Abnormal Findings in Retinal imaging and Eye Examinations
Time Frame: Upto 5 Years
Number of participants with abnormal findings in retinal imaging (Fundus Autofluorescence, Spectral Domain Optical Coherence Tomography, Color Fundus Photography) and eye examinations will be reported.
Upto 5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2024

Primary Completion (Estimated)

August 24, 2029

Study Completion (Estimated)

July 16, 2030

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81201887MDG3002 (Other Identifier: Janssen Research & Development, LLC)
  • 2022-500747-21-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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