Recruiting NCT06635148
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JNJ-81201887, Sham Procedure.
- Who it may be relevant to
- Registry conditions: Geographic Atrophy, Macular Degeneration. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Belgium, Canada, China +13
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Long-term Extension Study for Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) in JNJ-81201887 Parent Clinical Studies
Overview
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.
Interventions
- Drug JNJ-81201887
No study intervention will be administered as part of this LTE study. - Other Sham Procedure
No study intervention will be administered as part of this LTE study.
Primary outcome measures
- Number of Participants with Ocular and Systemic Treatment-emergent Adverse Events (TEAEs) [Time frame: Upto 5 Years]
- Number of Participants with Abnormal Findings in Clinical Laboratory Assessments [Time frame: Upto 5 Years]
- Number of Participants with Abnormal Findings in Retinal imaging and Eye Examinations [Time frame: Upto 5 Years]
Eligibility criteria
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
Exclusion criteria
- There are no exclusion criteria for this LTE study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 45 centers
- Retina Associates Southwest PC — Tucson
- Retina Consultants of Orange County — Fullerton
- Shiley Eye Institute Jacobs Retina Center — La Jolla
- California Retina Consultants — Oxnard
- California Eye Medical Specialists — Pasadena
- Retina Consultants San Diego — Poway
- Bay Area Retina Associates — Walnut Creek
- Retina Group of Florida — Fort Lauderdale
- … and 37 more centers
Spain · 13 centers
Center list to be confirmed — check the primary protocol.
Germany · 7 centers
- Universitaets-Augenklinik Bonn — Bonn
- Klinikum Gottingen der Georg August Universitat — Göttingen
- Medizinische Hochschule Hannover — Hanover
- Universitaetsklinikum Leipzig — Leipzig
- Klinikum Ludwigshafen — Ludwigshafen am Rhein
- Augenzentrum am St Franziskus Hospital Munster — Münster
- Universitaetsklinikum Tuebingen — Tübingen
Italy · 6 centers
- Azienda Ospedaliero Universitaria di Ferrara — Ferrara
- ASST Fatebenefratelli Sacco — Milan
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico — Milan
- IRCCS Ospedale San Raffaele — Milan
- Azienda Ospedaliero Universitaria Luigi Vanvitelli — Naples
- Fondazione Policlinico Universitario A Gemelli IRCCS — Roma
Australia · 4 centers
- Centre for Eye Research Australia — East Melbourne
- Strathfield Retina Clinic — Strathfield
- Sydney Retina Clinic and Day Surgery — Sydney
- Sydney West Retina — Westmead
United Kingdom · 4 centers
Center list to be confirmed — check the primary protocol.
Belgium · 3 centers
- Ziekenhuis Oost-Limburg — Genk
- UZ Gent — Ghent
- UZ Leuven Gasthuisberg — Leuven
China · 3 centers
- Beijing Tongren Hospital CMU — Beijing
- West China Hospital Si Chuan University — Chengdu
- Shanghai General Hospital — Shanghai
Hungary · 3 centers
- Eszak Pesti Centrumkorhaz Honvedkorhaz — Budapest
- Ganglion Orvosi Központ — Pécs
- Zala Varmegyei Szent Rafael Korhaz — Zalaegerszeg
Portugal · 3 centers
- Uls Coimbra - Hosp. Univ. Coimbra — Coimbra
- … and 2 more centers
Turkey (Türkiye) · 3 centers
Center list to be confirmed — check the primary protocol.
Czechia · 2 centers
- Fakultni nemocnice Kralovske Vinohrady — Prague
- AXON Clinical s.r.o. — Prague
Netherlands · 2 centers
- Radboudumc — Nijmegen
- Het Oogziekenhuis Rotterdam — Rotterdam
Poland · 2 centers
- Oftalmika — Bydgoszcz
- Warszawski Szpital Okulistyczny — Warsaw
Canada · 1 center
- Alberta Retina Consultants — Edmonton
Denmark · 1 center
- University Hospital Of Copenhagen, Glostrup Hospital — Glostrup Municipality
Sweden · 1 center
Center list to be confirmed — check the primary protocol.
Switzerland · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06635148 · 81201887MDG3002 · 81201887MDG3002 · 2022-500747-21-00