Geographic Atrophy

Macular Degeneration

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.

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

Retinal diseases

Eye Conditions

JNJ-81201887

Sham Procedure

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

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.

Number of participants with abnormal findings in clinical laboratory Assessments (including hematology and clinical chemistry) will be reported.

Number of participants with abnormal findings in retinal imaging (Fundus Autofluorescence, Spectral Domain Optical Coherence Tomography) and eye examinations will be reported.

BCVA will be assessed using the ETDRS chart at a starting distance of 4 meters. The ETDRS score ranges from 0 to 100 letters, where an increase in the number of letters read correctly means that vision has improved and vice-versa.

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.

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.

Participants randomized to the sham arm in parent study 81201887MDG2001 (NCT05811351) will enter this LTE study. No intervention will be administered as part of this study.

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.

Retina Associates Southwest PC

Retina Consultants of Orange County

Shiley Eye Institute Jacobs Retina Center

California Retina Consultants

Retina Consultants San Diego

Bay Area Retina Associates

Retina Group of Florida

VitreoRetinal Associates, PA

Retina Specialty Institute

Retina Vitreous Associates of Florida

Marietta Eye Clinic

University Retina

Midwest Eye Institute

Maine Eye Center

Retina Specialists

The Retina Group of Washington

Cumberland Valley Retina Consultants

Ophthalmic Consultants of Boston

Foundation for Vision Research

Retina Consultants of Minnesota

The Retina Institute

Sierra Eye Associates

Retina-Vitreous Surgeons of Central New York

Asheville Eye Associates - Western Carolina Retinal Associates

Duke Eye Center

Graystone Eye

NC Retina Associates

Cincinnati Eye Institute

Erie Retina Research

Charleston Neuroscience Institute, LLC

Retina and Vitreous of Texas, PLLC

Texas Retina Associates

UT Southwestern Medical Center

Retina Associates Of South Texas P A

Retina Consultants of Texas

Strategic Clinical Research Group

Piedmont Eye Center

Wagner Kapoor Research institute

Spokane Eye Clinical Research

Strathfield Retina Clinic

Ziekenhuis Oost-Limburg

UZ Gent

UZ Leuven Gasthuisberg

Beijing Tongren Hospital CMU

Shanghai General Hospital

Fakultni nemocnice Kralovske Vinohrady

AXON Clinical s.r.o.

University Hospital Of Copenhagen, Glostrup Hospital

Medizinische Hochschule Hannover

Universitaetsklinikum Leipzig

Klinikum Ludwigshafen

Augenzentrum am St Franziskus Hospital Munster

Eszak Pesti Centrumkorhaz Honvedkorhaz

Ganglion Orvosi Központ

Zala Varmegyei Szent Rafael Korhaz

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Fondazione Policlinico Universitario A Gemelli IRCCS

Radboudumc

Het Oogziekenhuis Rotterdam

Oftalmika

Uls Coimbra - Hosp. Univ. Coimbra

Espaco Medico de Coimbra

Uls Sao Joao

Centro de Oftalmologia Barraquer

Centro Medico Teknon S.L.

Inst. Cat. de Retina

Clinica Oftalvist Valencia

Hosp. La Arruzafa

Hosp Univ Fund Jimenez Diaz

Hosp. Univ. 12 de Octubre

Clinica Baviera Madrid Castellana

Hosp. Univ. Pta. de Hierro Majadahonda

Clinica Univ. de Navarra

Idc Salud Hosp. Gral. de Catalunya

Hosp. Virgen Del Rocio

Hosp. Clinico Univ. Lozano Blesa

Inselspital Universitatsspital Bern

Hacettepe University Medical Faculty

Baskent University Ankara Hospital

Oxford Eye Hospital

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.

Number of participants with abnormal findings in clinical laboratory Assessments
(including hematology and clinical chemistry) will be reported.

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.

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.

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.

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.

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

Trials at a glance

Trials at a glance

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

Outcome measures

Primary outcome measures