RecruitingPhase 2NCT06635148

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


Sponsor

Janssen Research & Development, LLC

Enrollment

274 participants

Start Date

Sep 19, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 60 Years

Inclusion Criteria3

  • 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

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Interventions

DRUGJNJ-81201887

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

OTHERSham Procedure

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


Locations(104)

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

Foundation for Vision Research

Grand Rapids, Michigan, United States

Retina Consultants of Minnesota

Saint Louis Park, Minnesota, United States

The Retina Institute

St Louis, Missouri, United States

Sierra Eye Associates

Reno, Nevada, United States

Retina-Vitreous Surgeons of Central New York

Liverpool, New York, United States

Asheville Eye Associates - Western Carolina Retinal Associates

Asheville, North Carolina, United States

Duke Eye Center

Durham, North Carolina, United States

Graystone Eye

Hickory, North Carolina, United States

NC Retina Associates

Wake Forest, North Carolina, United States

Cincinnati Eye Institute

Cincinnati, Ohio, United States

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

Verum Research LLC

Eugene, Oregon, United States

Cascade Medical Research Institute, LLC

Springfield, Oregon, United States

Erie Retina Research

Erie, Pennsylvania, United States

Charleston Neuroscience Institute, LLC

Beaufort, South Carolina, United States

Austin Clinical Research

Austin, Texas, United States

Texas Retina Associates

Dallas, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Retina Associates Of South Texas P A

San Antonio, Texas, United States

Retina Consultants of Texas

The Woodlands, Texas, United States

Strategic Clinical Research Group

Willow Park, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Piedmont Eye Center

Lynchburg, Virginia, United States

Wagner Kapoor Research institute

Norfolk, Virginia, United States

Spokane Eye Clinical Research

Spokane, Washington, United States

Centre for Eye Research Australia

East Melbourne, Australia

Strathfield Retina Clinic

Strathfield, Australia

Sydney Retina Clinic and Day Surgery

Sydney, Australia

Sydney West Retina

Westmead, Australia

Ziekenhuis Oost-Limburg

Genk, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven Gasthuisberg

Leuven, Belgium

Alberta Retina Consultants

Edmonton, Alberta, Canada

Beijing Tongren Hospital CMU

Beijing, China

West China Hospital Si Chuan University

Chengdu, China

Shanghai General Hospital

Shanghai, China

Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

AXON Clinical s.r.o.

Prague, Czechia

University Hospital Of Copenhagen, Glostrup Hospital

Glostrup Municipality, Denmark

Universitaets-Augenklinik Bonn

Bonn, Germany

Klinikum Gottingen der Georg August Universitat

Göttingen, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitaetsklinikum Leipzig

Leipzig, Germany

Klinikum Ludwigshafen

Ludwigshafen am Rhein, Germany

Augenzentrum am St Franziskus Hospital Munster

Münster, Germany

Universitaetsklinikum Tuebingen

Tübingen, Germany

Eszak Pesti Centrumkorhaz Honvedkorhaz

Budapest, Hungary

Ganglion Orvosi Központ

Pécs, Hungary

Zala Varmegyei Szent Rafael Korhaz

Zalaegerszeg, Hungary

Azienda Ospedaliero Universitaria di Ferrara

Ferrara, Italy

ASST Fatebenefratelli Sacco

Milan, Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Azienda Ospedaliero Universitaria Luigi Vanvitelli

Naples, Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, Italy

Radboudumc

Nijmegen, Netherlands

Het Oogziekenhuis Rotterdam

Rotterdam, Netherlands

Oftalmika

Bydgoszcz, Poland

Warszawski Szpital Okulistyczny

Warsaw, Poland

Uls Coimbra - Hosp. Univ. Coimbra

Coimbra, Portugal

Espaco Medico de Coimbra

Coimbra, Portugal

Uls Sao Joao

Porto, Portugal

Centro de Oftalmologia Barraquer

Barcelona, Spain

Centro Medico Teknon S.L.

Barcelona, Spain

Inst. Cat. de Retina

Barcelona, Spain

Clinica Oftalvist Valencia

Burjassot, Spain

Hosp. La Arruzafa

Córdoba, Spain

Hosp Univ Fund Jimenez Diaz

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Clinica Baviera Madrid Castellana

Madrid, Spain

Hosp. Univ. Pta. de Hierro Majadahonda

Majadahonda, Spain

Clinica Univ. de Navarra

Pamplona, Spain

Idc Salud Hosp. Gral. de Catalunya

Sant Cugat del Vallès, Spain

Hosp. Virgen Del Rocio

Seville, Spain

Hosp. Clinico Univ. Lozano Blesa

Zaragoza, Spain

S:t Eriks Ogonsjukhus

Stockholm, Sweden

Inselspital Universitatsspital Bern

Bern, Switzerland

Hacettepe University Medical Faculty

Ankara, Turkey (Türkiye)

Baskent University Ankara Hospital

Ankara, Turkey (Türkiye)

Dokuz Eylul University Medical Faculty

Izmir, Turkey (Türkiye)

Bristol Eye Hospital

Bristol, United Kingdom

Oxford Eye Hospital

Headington, United Kingdom

The Retina Clinic London

London, United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom

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NCT06635148


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