Clinical trial 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)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Geographic Atrophy
Macular Degeneration
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-10-10
Enrollment: 311
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Long-term safety study of a single intravitreal dose of JNJ-81201887 administered during parent studies (81201887MDG2001: Randomized trial; 81201887MDG1003: Non-randomized trial)
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants with Ocular and Systemic Treatment-emergent Adverse Events (TEAEs)
timeFrame: Upto 5 Years
measure: Number of Participants with Abnormal Findings in Clinical Laboratory Assessments
timeFrame: Upto 5 Years
measure: Number of Participants with Abnormal Findings in Retinal imaging and Eye Examinations
timeFrame: Upto 5 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Retina Associates Southwest PC
state: Arizona
city: Fullerton
country: United States
facility: Retina Consultants of Orange County
state: California
city: La Jolla
country: United States
facility: Shiley Eye Institute Jacobs Retina Center
state: California
city: Poway
country: United States
facility: Retina Consultants San Diego
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Gainesville
country: United States
facility: VitreoRetinal Associates, PA
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Marietta
country: United States
facility: Marietta Eye Clinic
state: Georgia
city: Portland
country: United States
facility: Maine Eye Center
state: Maine
city: Baltimore
country: United States
facility: Retina Specialists
state: Maryland
city: Chevy Chase
country: United States
facility: The Retina Group of Washington
state: Maryland
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Grand Rapids
country: United States
facility: Foundation for Vision Research
state: Michigan
city: Saint Louis Park
country: United States
facility: Retina Consultants of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: The Retina Institute
state: Missouri
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Liverpool
country: United States
facility: Retina-Vitreous Surgeons of Central New York
state: New York
city: Asheville
country: United States
facility: Asheville Eye Associates - Western Carolina Retinal Associates
state: North Carolina
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
city: Hickory
country: United States
facility: Graystone Eye
state: North Carolina
city: Wake Forest
country: United States
facility: NC Retina Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Erie
country: United States
facility: Erie Retina Research
state: Pennsylvania
city: Beaufort
country: United States
facility: Charleston Neuroscience Institute, LLC
state: South Carolina
city: Bellaire
country: United States
facility: Retina and Vitreous of Texas, PLLC
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group
state: Texas
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Norfolk
country: United States
facility: Wagner Kapoor Research institute
state: Virginia
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Shanghai
country: China
facility: Shanghai General Hospital
city: Prague
country: Czechia
facility: AXON Clinical s.r.o.
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Muenster
country: Germany
facility: Augenzentrum am St Franziskus Hospital Munster
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Bydgoszcz
country: Poland
facility: Oftalmika
city: Barcelona
country: Spain
facility: Centro de Oftalmologia Barraquer
city: Barcelona
country: Spain
facility: Centro Medico Teknon S.L.
city: Barcelona
country: Spain
facility: Inst. Cat. de Retina
city: Burjassot
country: Spain
facility: Clinica Oftalvist Valencia
city: Cordoba
country: Spain
facility: Hosp. La Arruzafa
city: Madrid
country: Spain
facility: Hosp Univ Fund Jimenez Diaz
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Madrid
country: Spain
facility: Clinica Baviera Madrid Castellana
city: Majadahonda
country: Spain
facility: Hosp. Univ. Pta. de Hierro Majadahonda
city: Pamplona
country: Spain
facility: Clinica Univ. de Navarra
city: Sant Cugat del Valles
country: Spain
facility: Idc Salud Hosp. Gral. de Catalunya
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Ankara
country: Turkey
facility: Baskent University Ankara Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: