Clinical trial NCT05811351: A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Official title: A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Geographic Atrophy
Keywords: Macular Degeneration
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-04-13
Enrollment: 305
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate change in geographic atrophy (GA) lesion growth of eyes treated with JNJ-81201887 compared to sham control.


Eligibility criteria: Inclusion Criteria:

* Have non-subfoveal (defined as not involving the center point of the fovea) geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an area that can be measured and measures 2.5 millimeter square (mm\^2) to 17.5 mm\^2 (1- and 7- disc areas respectively), determined by the central reading center (CRC) from screening images of fundus autofluorescence (FAF) and spectral domain optical coherence tomography (SD-OCT)
* If GA is multifocal, at least one focal lesion must be greater than or equal to (\>=) 1.25 mm\^2 (0.5- disc area), as assessed by the CRC
* GA can be photographed in its entirety by FAF, using a 30- degree image centered on the fovea, as assessed by the CRC
* Fellow eye must be present with a best corrected distance visual acuity (BCVA) of counting fingers or better
* Man or woman (according to their reproductive organs and functions assigned by chromosomal complement)

Exclusion Criteria:

* History of transpupillary thermotherapy, photodynamic therapy or external-beam radiation therapy in the region of study eye
* Any prior thermal laser in the macular region, regardless of indication
* History of retinal detachment (with or without repair)
* Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
* Any sign of diabetic retinopathy or central serous chorioretinopathy

Primary outcomes:
measure: Global: Change From Baseline in Square Root of Geographic Atrophy (GA) Lesion Area in the Study Eye at Month 18
timeFrame: Baseline and Month 18
measure: United States (U.S.) Specific: Rate of Change in Untransformed GA Lesion Area in the Study Eye
timeFrame: Baseline to Month 18
Secondary outcomes:
measure: Change From Baseline in Low Luminance Visual Acuity (LLVA) at Month 18
timeFrame: Baseline and Month 18
measure: Change From Baseline in Reading Speed at Month 18
timeFrame: Baseline and Month 18
measure: Change From Baseline in Retinal Sensitivity by Mesopic Microperimetry (MAIA) at Month 18
timeFrame: Baseline and Month 18
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 18
timeFrame: Baseline and Month 18
measure: Change From Baseline in Functional Reading Independence (FRI) Index at Month 18
timeFrame: Baseline and Month 18
measure: Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at Month 18
timeFrame: Baseline and Month 18
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Research Institute
state: Arizona
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: Huntington Beach
country: United States
facility: Retina Associates Of Southern California
state: California
city: La Jolla
country: United States
facility: Shiley Eye Institute Jacobs Retina Center
state: California
city: Los Angeles
country: United States
facility: Jules Stein Eye Institute UCLA
state: California
city: Los Angeles
country: United States
facility: The Retina Partners
state: California
city: Oxnard
country: United States
facility: California Retina Consultants
state: California
city: Palo Alto
country: United States
facility: Stanford Health Care
state: California
city: Pasadena
country: United States
facility: California Eye Medical Specialists
state: California
city: Poway
country: United States
facility: Retina Consultants San Diego
state: California
city: Redlands
country: United States
facility: Retina Consultants of Southern California
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Lakewood
country: United States
facility: Colorado Retina - Lakewood Clinic
state: Colorado
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Fort Myers
country: United States
facility: National Opthalmic Research Institute
state: Florida
city: Gainesville
country: United States
facility: VitreoRetinal Associates, PA
state: Florida
city: Miami
country: United States
facility: MedEye Associates
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Plantation
country: United States
facility: Fort Lauderdale Eye Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Stuart
country: United States
facility: East Florida Eye Institute
state: Florida
city: Marietta
country: United States
facility: Georgia Retina
state: Georgia
city: Marietta
country: United States
facility: Marietta Eye Clinic
state: Georgia
city: Chicago
country: United States
facility: University Of Illinois
state: Illinois
city: Elmhurst
country: United States
facility: Retina Associates
state: Illinois
city: Lemont
country: United States
facility: University Retina
state: Illinois
city: Carmel
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Portland
country: United States
facility: Maine Eye Center
state: Maine
city: Baltimore
country: United States
facility: Retina Specialists
state: Maryland
city: Baltimore
country: United States
facility: The Retina Care Center
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: Worcester
country: United States
facility: Vitreo Retinal Associates-Worcester
state: Massachusetts
city: Grand Rapids
country: United States
facility: Foundation for Vision Research
state: Michigan
city: Royal Oak
country: United States
facility: Associated Retinal Consultants P.C.
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: Cherry Hill
country: United States
facility: Wills Eye/Mid Atlantic Retina
state: New Jersey
city: Great Neck
country: United States
facility: Long Island Vitreo Retinal Consultants
state: New York
city: Liverpool
country: United States
facility: Retina-Vitreous Surgeons of Central New York
state: New York
city: New York
country: United States
facility: Vitreous Retina Macula Consultants of New York
state: New York
city: Slingerlands
country: United States
facility: Retina Consultants PLLC
state: New York
city: Troy
country: United States
facility: Opthalmic Consultants of the Capital Region
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 University
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: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Eugene
country: United States
facility: Verum Research LLC
state: Oregon
city: Portland
country: United States
facility: Casey Eye Institute
state: Oregon
city: Springfield
country: United States
facility: Cascade Medical Research Institute, LLC
state: Oregon
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: Germantown
country: United States
facility: Charles Retina Institute
state: Tennessee
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Amarillo
country: United States
facility: Panhandle Eye Group LLP-Southwest Retina Specialists
state: Texas
city: Austin
country: United States
facility: Austin Clinical Research
state: Texas
city: Bellaire
country: United States
facility: Retina and Vitreous of Texas, PLLC
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Fort Worth
country: United States
facility: Texas Retina Associates
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: San Antonio
country: United States
facility: San Antonio Eye Center
state: Texas
city: San Antonio
country: United States
facility: Retina Associates Of South Texas P A
state: Texas
city: San Antonio
country: United States
facility: Retina Consultants of Texas
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: Salt Lake City
country: United States
facility: Retina Associates of Utah P C
state: Utah
city: Salt Lake City
country: United States
facility: Rocky Mountain Retina Consultants
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
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: Adelaide
country: Australia
facility: Adelaide Eye and Retina Centre
city: East Melbourne
country: Australia
facility: Centre for Eye Research Australia
city: Strathfield
country: Australia
facility: Strathfield Retina Clinic
city: Sydney
country: Australia
facility: Sydney Retina Clinic and Day Surgery
city: Westmead
country: Australia
facility: Sydney West Retina
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
city: Calgary
country: Canada
facility: Calgary Retina Consultants
state: Alberta
city: Edmonton
country: Canada
facility: Alberta Retina Consultants
state: Alberta
city: Ottawa
country: Canada
facility: The Ottawa Hospital Research Institute
state: Ontario
city: Ottawa
country: Canada
facility: The Retina Centre of Ottawa
state: Ontario
city: Boisbriand
country: Canada
facility: Institut De L'oeil Des Laurentides
state: Quebec
city: Pardubice
country: Czechia
facility: OFTEX Ltd. - EYE CENTER
city: Prague
country: Czechia
facility: AXON Clinical s.r.o.
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Glostrup
country: Denmark
facility: University Hospital Of Copenhagen, Glostrup Hospital
city: Roskilde
country: Denmark
facility: Zealand University Hospital
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin
city: Bonn
country: Germany
facility: Universitaets-Augenklinik Bonn
city: Giessen
country: Germany
facility: Universitatsklinikum Gießen - Klinik und Poliklinik fur Augenheilkunde
city: Gottingen
country: Germany
facility: Klinikum Gottingen der Georg August Universitat
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig Holstein Kiel
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: Ludwigshafen am Rhein
country: Germany
facility: Klinikum Ludwigshafen
city: Muenster
country: Germany
facility: Augenzentrum am St Franziskus Hospital Munster
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Budapest
country: Hungary
facility: Eszak Pesti Centrumkorhaz Honvedkorhaz
city: Pecs
country: Hungary
facility: Ganglion Orvosi Központ
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Korhaz
city: Ferrara
country: Italy
facility: Arcispedale S. Anna Ferrara
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Milano
country: Italy
facility: Sacco Hospital
city: Napoli
country: Italy
facility: Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Centers Location Academic Medical Center
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Rotterdam
country: Netherlands
facility: Het Oogziekenhuis Rotterdam
city: Bydgoszcz
country: Poland
facility: Oculomedica
city: Bydgoszcz
country: Poland
facility: Oftalmika
city: Tarnow
country: Poland
facility: Uno Med
city: Warszawa
country: Poland
facility: Warszawski Szpital Okulistyczny
city: Coimbra
country: Portugal
facility: Uls Coimbra - Hosp. Univ. Coimbra
city: Coimbra
country: Portugal
facility: Espaco Medico de Coimbra
city: Porto
country: Portugal
facility: Uls Sao Joao - Hosp. Sao Joao
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: Barcelona
country: Spain
facility: Hosp. Dos de Maig
city: Barcelona
country: Spain
facility: Inst. de Microcirugia Ocular
city: Burjassot
country: Spain
facility: Clinica Oftalvist Valencia
city: Cordoba
country: Spain
facility: Hosp. La Arruzafa
city: Donostia San Sebastian
country: Spain
facility: Hosp. Univ. Donostia
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: Santiago de Compostela
country: Spain
facility: Hosp. Prov. Do Conxo
city: Sevilla
country: Spain
facility: Hosp. Virgen Del Rocio
city: Zaragoza
country: Spain
facility: Hosp. Clinico Univ. Lozano Blesa
city: Zaragoza
country: Spain
facility: Hosp. Univ. Miguel Servet
city: Stockholm
country: Sweden
facility: S:t Eriks Ogonsjukhus
city: Bern
country: Switzerland
facility: Inselspital Universitatsspital Bern
city: Ankara
country: Turkey
facility: Hacettepe University Hospital
city: Ankara
country: Turkey
facility: Baskent University Ankara Hospital
city: Ankara
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi
city: İzmir
country: Turkey
facility: Dokuz Eylul University Hospital
city: Konya
country: Turkey
facility: Konya Selcuk University Medical Faculty
city: Bristol
country: United Kingdom
facility: Bristol Eye Hospital
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
city: London
country: United Kingdom
facility: Central Middlesex Hospital
city: London
country: United Kingdom
facility: The Retina Clinic London
city: Manchester
country: United Kingdom
facility: Manchester Royal Eye Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Oxford
country: United Kingdom
facility: Oxford Eye Hospital
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: