A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
- Conditions
- Geographic AtrophyMacular Degeneration
- Interventions
- Other: Sham Procedure
- Registration Number
- NCT06635148
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 311
- 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
- There are no exclusion criteria for this LTE study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: JNJ-81201887 Low Dose JNJ-81201887 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. Arm B: JNJ-81201887 High dose JNJ-81201887 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. Arm C: Sham Procedure 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.
- Primary Outcome Measures
Name Time Method Number of Participants with Ocular and Systemic Treatment-emergent Adverse Events (TEAEs) 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.
Number of Participants with Abnormal Findings in Clinical Laboratory Assessments Upto 5 Years 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 and Eye Examinations 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.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (56)
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Ziekenhuis Oost-Limburg
🇧🇪Genk, Belgium
AXON Clinical s.r.o.
🇨🇿Prague, Czechia
Fakultni nemocnice Kralovske Vinohrady
🇨🇿Praha 10, Czechia
Inst. Cat. de Retina
🇪🇸Barcelona, Spain
Hosp. La Arruzafa
🇪🇸Cordoba, Spain
Hosp Univ Fund Jimenez Diaz
🇪🇸Madrid, Spain
Hosp. Univ. Pta. de Hierro Majadahonda
🇪🇸Majadahonda, Spain
Hacettepe University Medical Faculty
🇹🇷Ankara, Turkey
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
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
🇺🇸Saint Petersburg, Florida, United States
Marietta Eye Clinic
🇺🇸Marietta, Georgia, 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
Foundation for Vision Research
🇺🇸Grand Rapids, Michigan, United States
Retina Consultants of Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
The Retina Institute
🇺🇸Saint 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
Erie Retina Research
🇺🇸Erie, Pennsylvania, United States
Charleston Neuroscience Institute, LLC
🇺🇸Beaufort, South Carolina, United States
Retina and Vitreous of Texas, PLLC
🇺🇸Bellaire, Texas, United States
Texas Retina Associates
🇺🇸Dallas, Texas, United States
Retina Consultants of Texas
🇺🇸The Woodlands, Texas, United States
Strategic Clinical Research Group
🇺🇸Willow Park, Texas, 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
Shanghai General Hospital
🇨🇳Shanghai, China
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Augenzentrum am St Franziskus Hospital Munster
🇩🇪Muenster, Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Radboudumc
🇳🇱Nijmegen, Netherlands
Oftalmika
🇵🇱Bydgoszcz, Poland
Centro de Oftalmologia Barraquer
🇪🇸Barcelona, Spain
Centro Medico Teknon S.L.
🇪🇸Barcelona, Spain
Clinica Oftalvist Valencia
🇪🇸Burjassot, Spain
Hosp. Univ. 12 de Octubre
🇪🇸Madrid, Spain
Clinica Baviera Madrid Castellana
🇪🇸Madrid, Spain
Clinica Univ. de Navarra
🇪🇸Pamplona, Spain
Idc Salud Hosp. Gral. de Catalunya
🇪🇸Sant Cugat del Valles, Spain
Baskent University Ankara Hospital
🇹🇷Ankara, Turkey