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
2 other identifiers
interventional
274
18 countries
104
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2024
Longer than P75 for phase_2
104 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 19, 2024
CompletedFirst Submitted
Initial submission to the registry
September 23, 2024
CompletedFirst Posted
Study publicly available on registry
October 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 16, 2030
April 13, 2026
April 1, 2026
4.9 years
September 23, 2024
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Number of Participants with Ocular and Systemic Treatment-emergent Adverse Events (TEAEs)
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
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
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
Study Arms (3)
Arm A: JNJ-81201887 Low Dose
EXPERIMENTALStudy 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.
Arm B: JNJ-81201887 High dose
EXPERIMENTALStudy 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.
Arm C: Sham Procedure
SHAM COMPARATORParticipants 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
No study intervention will be administered as part of this LTE study.
No study intervention will be administered as part of this LTE study.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (104)
Retina Associates Southwest PC
Tucson, Arizona, 85704, United States
Retina Consultants of Orange County
Fullerton, California, 92835, United States
Shiley Eye Institute Jacobs Retina Center
La Jolla, California, 92093 0946, United States
California Retina Consultants
Oxnard, California, 93036, United States
California Eye Medical Specialists
Pasadena, California, 91107, United States
Retina Consultants San Diego
Poway, California, 92064, United States
Bay Area Retina Associates
Walnut Creek, California, 94598, United States
Retina Group of Florida
Fort Lauderdale, Florida, 33308, United States
VitreoRetinal Associates, PA
Gainesville, Florida, 32607, United States
Retina Specialty Institute
Pensacola, Florida, 32503, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711, United States
Georgia Retina
Marietta, Georgia, 30060, United States
Marietta Eye Clinic
Marietta, Georgia, 30060, United States
University Retina
Lemont, Illinois, 60439, United States
Midwest Eye Institute
Carmel, Indiana, 46032, United States
Maine Eye Center
Portland, Maine, 04101, United States
Retina Specialists
Baltimore, Maryland, 21204, United States
The Retina Group of Washington
Chevy Chase, Maryland, 20815, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Foundation for Vision Research
Grand Rapids, Michigan, 49546, United States
Retina Consultants of Minnesota
Saint Louis Park, Minnesota, 55416, United States
The Retina Institute
St Louis, Missouri, 63128, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Retina-Vitreous Surgeons of Central New York
Liverpool, New York, 13088, United States
Asheville Eye Associates - Western Carolina Retinal Associates
Asheville, North Carolina, 28803, United States
Duke Eye Center
Durham, North Carolina, 27705, United States
Graystone Eye
Hickory, North Carolina, 28602, United States
NC Retina Associates
Wake Forest, North Carolina, 27587, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195, United States
Verum Research LLC
Eugene, Oregon, 97401, United States
Cascade Medical Research Institute, LLC
Springfield, Oregon, 97477, United States
Erie Retina Research
Erie, Pennsylvania, 16505, United States
Charleston Neuroscience Institute, LLC
Beaufort, South Carolina, 29902, United States
Austin Clinical Research
Austin, Texas, 78750, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Retina Associates Of South Texas P A
San Antonio, Texas, 78240, United States
Retina Consultants of Texas
The Woodlands, Texas, 77384, United States
Strategic Clinical Research Group
Willow Park, Texas, 76087, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Piedmont Eye Center
Lynchburg, Virginia, 24502, United States
Wagner Kapoor Research institute
Norfolk, Virginia, 23502, United States
Spokane Eye Clinical Research
Spokane, Washington, 99204, United States
Centre for Eye Research Australia
East Melbourne, 3002, Australia
Strathfield Retina Clinic
Strathfield, 2135, Australia
Sydney Retina Clinic and Day Surgery
Sydney, 2000, Australia
Sydney West Retina
Westmead, 2145, Australia
Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
UZ Gent
Ghent, 9000, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
Alberta Retina Consultants
Edmonton, Alberta, T5H 0X5, Canada
Beijing Tongren Hospital CMU
Beijing, 100730, China
West China Hospital Si Chuan University
Chengdu, 610041, China
Shanghai General Hospital
Shanghai, 200080, China
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
AXON Clinical s.r.o.
Prague, 15000, Czechia
University Hospital Of Copenhagen, Glostrup Hospital
Glostrup Municipality, 2600, Denmark
Universitaets-Augenklinik Bonn
Bonn, 53127, Germany
Klinikum Gottingen der Georg August Universitat
Göttingen, 37075, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitaetsklinikum Leipzig
Leipzig, 04103, Germany
Klinikum Ludwigshafen
Ludwigshafen am Rhein, 67063, Germany
Augenzentrum am St Franziskus Hospital Munster
Münster, 48145, Germany
Universitaetsklinikum Tuebingen
Tübingen, 72076, Germany
Eszak Pesti Centrumkorhaz Honvedkorhaz
Budapest, 1062, Hungary
Ganglion Orvosi Központ
Pécs, 7621, Hungary
Zala Varmegyei Szent Rafael Korhaz
Zalaegerszeg, 8900, Hungary
Azienda Ospedaliero Universitaria di Ferrara
Ferrara, 44124, Italy
ASST Fatebenefratelli Sacco
Milan, 20157, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Azienda Ospedaliero Universitaria Luigi Vanvitelli
Naples, 80138, Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168, Italy
Radboudumc
Nijmegen, 6525 GA, Netherlands
Het Oogziekenhuis Rotterdam
Rotterdam, 3011, Netherlands
Oftalmika
Bydgoszcz, 85 631, Poland
Warszawski Szpital Okulistyczny
Warsaw, 01 258, Poland
Uls Coimbra - Hosp. Univ. Coimbra
Coimbra, 3000 075, Portugal
Espaco Medico de Coimbra
Coimbra, 3030 163, Portugal
Uls Sao Joao
Porto, 4200 319, Portugal
Centro de Oftalmologia Barraquer
Barcelona, 08021, Spain
Centro Medico Teknon S.L.
Barcelona, 08022, Spain
Inst. Cat. de Retina
Barcelona, 08022, Spain
Clinica Oftalvist Valencia
Burjassot, 46100, Spain
Hosp. La Arruzafa
Córdoba, 14012, Spain
Hosp Univ Fund Jimenez Diaz
Madrid, 28040, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Clinica Baviera Madrid Castellana
Madrid, 28046, Spain
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, 28222, Spain
Clinica Univ. de Navarra
Pamplona, 31008, Spain
Idc Salud Hosp. Gral. de Catalunya
Sant Cugat del Vallès, 08195, Spain
Hosp. Virgen Del Rocio
Seville, 41013, Spain
Hosp. Clinico Univ. Lozano Blesa
Zaragoza, 50009, Spain
S:t Eriks Ogonsjukhus
Stockholm, 171 64, Sweden
Inselspital Universitatsspital Bern
Bern, 3010, Switzerland
Hacettepe University Medical Faculty
Ankara, 06230, Turkey (Türkiye)
Baskent University Ankara Hospital
Ankara, 06490, Turkey (Türkiye)
Dokuz Eylul University Medical Faculty
Izmir, 35330, Turkey (Türkiye)
Bristol Eye Hospital
Bristol, BS1 2LX, United Kingdom
Oxford Eye Hospital
Headington, OX3 9DU, United Kingdom
The Retina Clinic London
London, W1G 9AX, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2024
First Posted
October 10, 2024
Study Start
September 19, 2024
Primary Completion (Estimated)
August 24, 2029
Study Completion (Estimated)
July 16, 2030
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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