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

NCT ID: NCT06635148

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

311 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-19

Study Completion Date

2030-06-27

Brief Summary

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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.

Detailed Description

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Conditions

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Geographic Atrophy Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Long-term safety study of a single intravitreal dose of JNJ-81201887 administered during parent studies (81201887MDG2001: Randomized trial; 81201887MDG1003: Non-randomized trial)
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

JNJ-81201887

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

JNJ-81201887

Intervention Type DRUG

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

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.

Group Type SHAM_COMPARATOR

Sham Procedure

Intervention Type OTHER

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

Interventions

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JNJ-81201887

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

Intervention Type DRUG

Sham Procedure

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Retina Associates Southwest PC

Tucson, Arizona, United States

Site Status RECRUITING

Retina Consultants of Orange County

Fullerton, California, United States

Site Status RECRUITING

Shiley Eye Institute Jacobs Retina Center

La Jolla, California, United States

Site Status RECRUITING

California Retina Consultants

Oxnard, California, United States

Site Status RECRUITING

California Eye Medical Specialists

Pasadena, California, United States

Site Status RECRUITING

Retina Consultants San Diego

Poway, California, United States

Site Status RECRUITING

Bay Area Retina Associates

Walnut Creek, California, United States

Site Status RECRUITING

Retina Group of Florida

Fort Lauderdale, Florida, United States

Site Status RECRUITING

VitreoRetinal Associates, PA

Gainesville, Florida, United States

Site Status RECRUITING

Retina Specialty Institute

Pensacola, Florida, United States

Site Status RECRUITING

Retina Vitreous Associates of Florida

St. Petersburg, Florida, United States

Site Status RECRUITING

Georgia Retina

Marietta, Georgia, United States

Site Status RECRUITING

Marietta Eye Clinic

Marietta, Georgia, United States

Site Status RECRUITING

University Retina

Lemont, Illinois, United States

Site Status RECRUITING

Midwest Eye Institute

Carmel, Indiana, United States

Site Status RECRUITING

Maine Eye Center

Portland, Maine, United States

Site Status RECRUITING

Retina Specialists

Baltimore, Maryland, United States

Site Status RECRUITING

The Retina Group of Washington

Chevy Chase, Maryland, United States

Site Status RECRUITING

Cumberland Valley Retina Consultants

Hagerstown, Maryland, United States

Site Status RECRUITING

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status RECRUITING

Foundation for Vision Research

Grand Rapids, Michigan, United States

Site Status RECRUITING

Retina Consultants of Minnesota

Saint Louis Park, Minnesota, United States

Site Status RECRUITING

The Retina Institute

St Louis, Missouri, United States

Site Status RECRUITING

Sierra Eye Associates

Reno, Nevada, United States

Site Status RECRUITING

Retina-Vitreous Surgeons of Central New York

Liverpool, New York, United States

Site Status RECRUITING

Asheville Eye Associates - Western Carolina Retinal Associates

Asheville, North Carolina, United States

Site Status RECRUITING

Duke Eye Center

Durham, North Carolina, United States

Site Status RECRUITING

Graystone Eye

Hickory, North Carolina, United States

Site Status RECRUITING

NC Retina Associates

Wake Forest, North Carolina, United States

Site Status RECRUITING

Cincinnati Eye Institute

Cincinnati, Ohio, United States

Site Status RECRUITING

Verum Research LLC

Eugene, Oregon, United States

Site Status RECRUITING

Cascade Medical Research Institute, LLC

Springfield, Oregon, United States

Site Status RECRUITING

Erie Retina Research

Erie, Pennsylvania, United States

Site Status RECRUITING

Charleston Neuroscience Institute, LLC

Beaufort, South Carolina, United States

Site Status RECRUITING

Austin Clinical Research

Austin, Texas, United States

Site Status RECRUITING

Retina and Vitreous of Texas, PLLC

Bellaire, Texas, United States

Site Status RECRUITING

Texas Retina Associates

Dallas, Texas, United States

Site Status RECRUITING

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Retina Associates Of South Texas P A

San Antonio, Texas, United States

Site Status RECRUITING

Retina Consultants of Texas

The Woodlands, Texas, United States

Site Status RECRUITING

Strategic Clinical Research Group

Willow Park, Texas, United States

Site Status RECRUITING

University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

Piedmont Eye Center

Lynchburg, Virginia, United States

Site Status RECRUITING

Wagner Kapoor Research institute

Norfolk, Virginia, United States

Site Status RECRUITING

Spokane Eye Clinical Research

Spokane, Washington, United States

Site Status RECRUITING

Centre for Eye Research Australia

East Melbourne, , Australia

Site Status RECRUITING

Strathfield Retina Clinic

Strathfield, , Australia

Site Status RECRUITING

Sydney West Retina

Westmead, , Australia

Site Status RECRUITING

Ziekenhuis Oost-Limburg

Genk, , Belgium

Site Status RECRUITING

UZ Gent

Ghent, , Belgium

Site Status RECRUITING

UZ Leuven Gasthuisberg

Leuven, , Belgium

Site Status RECRUITING

Alberta Retina Consultants

Edmonton, Alberta, Canada

Site Status RECRUITING

Beijing Tongren Hospital CMU

Beijing, , China

Site Status RECRUITING

Shanghai General Hospital

Shanghai, , China

Site Status RECRUITING

Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

Site Status RECRUITING

AXON Clinical s.r.o.

Prague, , Czechia

Site Status RECRUITING

University Hospital Of Copenhagen, Glostrup Hospital

Glostrup Municipality, , Denmark

Site Status ACTIVE_NOT_RECRUITING

Universitaets-Augenklinik Bonn

Bonn, , Germany

Site Status RECRUITING

Klinikum Gottingen der Georg August Universitat

Göttingen, , Germany

Site Status RECRUITING

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status RECRUITING

Universitaetsklinikum Leipzig

Leipzig, , Germany

Site Status RECRUITING

Klinikum Ludwigshafen

Ludwigshafen am Rhein, , Germany

Site Status RECRUITING

Augenzentrum am St Franziskus Hospital Munster

Münster, , Germany

Site Status RECRUITING

Universitaetsklinikum Tuebingen

Tübingen, , Germany

Site Status RECRUITING

Eszak Pesti Centrumkorhaz Honvedkorhaz

Budapest, , Hungary

Site Status RECRUITING

Ganglion Orvosi Központ

Pécs, , Hungary

Site Status RECRUITING

Zala Varmegyei Szent Rafael Korhaz

Zalaegerszeg, , Hungary

Site Status RECRUITING

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status RECRUITING

IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria Luigi Vanvitelli

Napoli, , Italy

Site Status RECRUITING

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, , Italy

Site Status RECRUITING

Radboudumc

Nijmegen, , Netherlands

Site Status RECRUITING

Het Oogziekenhuis Rotterdam

Rotterdam, , Netherlands

Site Status RECRUITING

Oftalmika

Bydgoszcz, , Poland

Site Status RECRUITING

Warszawski Szpital Okulistyczny

Warsaw, , Poland

Site Status RECRUITING

Uls Coimbra - Hosp. Univ. Coimbra

Coimbra, , Portugal

Site Status ACTIVE_NOT_RECRUITING

Espaco Medico de Coimbra

Coimbra, , Portugal

Site Status RECRUITING

Uls Sao Joao

Porto, , Portugal

Site Status RECRUITING

Centro de Oftalmologia Barraquer

Barcelona, , Spain

Site Status RECRUITING

Centro Medico Teknon S.L.

Barcelona, , Spain

Site Status RECRUITING

Inst. Cat. de Retina

Barcelona, , Spain

Site Status RECRUITING

Clinica Oftalvist Valencia

Burjassot, , Spain

Site Status RECRUITING

Hosp. La Arruzafa

Córdoba, , Spain

Site Status RECRUITING

Hosp Univ Fund Jimenez Diaz

Madrid, , Spain

Site Status RECRUITING

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

Clinica Baviera Madrid Castellana

Madrid, , Spain

Site Status RECRUITING

Hosp. Univ. Pta. de Hierro Majadahonda

Majadahonda, , Spain

Site Status RECRUITING

Clinica Univ. de Navarra

Pamplona, , Spain

Site Status RECRUITING

Idc Salud Hosp. Gral. de Catalunya

Sant Cugat del Vallès, , Spain

Site Status RECRUITING

Hosp. Virgen Del Rocio

Seville, , Spain

Site Status RECRUITING

Hosp. Clinico Univ. Lozano Blesa

Zaragoza, , Spain

Site Status RECRUITING

S:t Eriks Ogonsjukhus

Stockholm, , Sweden

Site Status ACTIVE_NOT_RECRUITING

Inselspital Universitatsspital Bern

Bern, , Switzerland

Site Status RECRUITING

Hacettepe University Medical Faculty

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Baskent University Ankara Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Bristol Eye Hospital

Bristol, , United Kingdom

Site Status RECRUITING

Oxford Eye Hospital

Headington, , United Kingdom

Site Status RECRUITING

The Retina Clinic London

London, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia Belgium Canada China Czechia Denmark Germany Hungary Italy Netherlands Poland Portugal Spain Sweden Switzerland Turkey (Türkiye) United Kingdom

Central Contacts

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Study Contact

Role: CONTACT

Phone: 844-434-4210

Email: [email protected]

Other Identifiers

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81201887MDG3002

Identifier Type: OTHER

Identifier Source: secondary_id

2022-500747-21-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

81201887MDG3002

Identifier Type: -

Identifier Source: org_study_id