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)
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)
3 other identifiers
interventional
305
17 countries
162
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2023
Typical duration for phase_2
162 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
March 6, 2023
CompletedFirst Submitted
Initial submission to the registry
March 7, 2023
CompletedFirst Posted
Study publicly available on registry
April 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2026
CompletedMarch 13, 2026
March 1, 2026
3 years
March 7, 2023
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Global: Change From Baseline in Square Root of Geographic Atrophy (GA) Lesion Area in the Study Eye at Month 18
Change from baseline in GA lesion area in the study at month 18 eye will be measured via retinal imaging using fundus auto fluorescence (FAF).
Baseline and Month 18
United States (U.S.) Specific: Rate of Change in Untransformed GA Lesion Area in the Study Eye
Rate of Change in untransformed GA lesion area in the study eye will be measured via retinal imaging using FAF. A piecewise linear mixed effects (PLME) model will be used for the primary efficacy analysis for rate of change in GA area (GAA) in the study eye.
Baseline to Month 18
Secondary Outcomes (6)
Change From Baseline in Low Luminance Visual Acuity (LLVA) at Month 18
Baseline and Month 18
Change From Baseline in Reading Speed at Month 18
Baseline and Month 18
Change From Baseline in Retinal Sensitivity by Mesopic Microperimetry (MAIA) at Month 18
Baseline and Month 18
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 18
Baseline and Month 18
Change From Baseline in Functional Reading Independence (FRI) Index at Month 18
Baseline and Month 18
- +1 more secondary outcomes
Study Arms (3)
Arm A: JNJ-81201887 Low Dose
EXPERIMENTALParticipants will receive a single low dose intravitreal injection of JNJ-81201887 in the study eye on Day 4. In addition, participants will receive a 20-day oral prednisone course starting on Day 1 and a single, long acting periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.
Arm B: JNJ-81201887 High dose
EXPERIMENTALParticipants will receive a single high dose intravitreal injection of JNJ-81201887 in the study eye on Day 4. In addition, participants will receive a 20-day oral prednisone course starting on Day 1 and a single, long acting periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.
Arm C: Sham Procedure
SHAM COMPARATORParticipants will receive sham procedure that matches the single JNJ21801887 injection on Day 4, a sham procedure that matches the long acting periocular triamcinolone (corticosteroid injection) on Day 4 and a 20-day placebo matching oral prednisone starting on Day 1.
Interventions
JNJ-81201887 will be administered as intravitreal injection.
Prednisone will be administered as oral capsule.
Triamcinolone (corticosteroid injection) periocular injection will be administered as per local practice.
Sham injections matching to single JNJ-81201887 injection and matching to corticosteroid (triamcinolone) periocular injection will be administered.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (162)
Retinal Research Institute
Phoenix, Arizona, 85053, United States
Retina Associates Southwest PC
Tucson, Arizona, 85704, United States
Retina Consultants of Orange County
Fullerton, California, 92835, United States
Retina Associates Of Southern California
Huntington Beach, California, 92647, United States
Shiley Eye Institute Jacobs Retina Center
La Jolla, California, 92093 0946, United States
Jules Stein Eye Institute UCLA
Los Angeles, California, 90095, United States
The Retina Partners
Los Angeles, California, 91436, United States
California Retina Consultants
Oxnard, California, 93036, United States
Stanford Health Care
Palo Alto, California, 94303, United States
California Eye Medical Specialists
Pasadena, California, 91107, United States
Retina Consultants San Diego
Poway, California, 92064, United States
Retina Consultants of Southern California
Redlands, California, 92374, United States
Bay Area Retina Associates
Walnut Creek, California, 94598, United States
Colorado Retina - Lakewood Clinic
Lakewood, Colorado, 80228, United States
Retina Group of Florida
Fort Lauderdale, Florida, 33308, United States
National Opthalmic Research Institute
Fort Myers, Florida, 33912, United States
VitreoRetinal Associates, PA
Gainesville, Florida, 32607, United States
MedEye Associates
Miami, Florida, 33143, United States
Retina Specialty Institute
Pensacola, Florida, 32503, United States
Fort Lauderdale Eye Institute
Plantation, Florida, 33324, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711, United States
East Florida Eye Institute
Stuart, Florida, 34994, United States
Georgia Retina
Marietta, Georgia, 30060, United States
Marietta Eye Clinic
Marietta, Georgia, 30060, United States
University Of Illinois
Chicago, Illinois, 60612, United States
Retina Associates
Elmhurst, Illinois, 60126, 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 Care Center
Baltimore, Maryland, 21209, 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
Vitreo Retinal Associates-Worcester
Worcester, Massachusetts, 01605, United States
Foundation for Vision Research
Grand Rapids, Michigan, 49546, United States
Associated Retinal Consultants P.C.
Royal Oak, Michigan, 48073, United States
Retina Consultants of Minnesota
Saint Louis Park, Minnesota, 55416, United States
The Retina Institute
St Louis, Missouri, 63144, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Wills Eye/Mid Atlantic Retina
Cherry Hill, New Jersey, 08034, United States
Long Island Vitreo Retinal Consultants
Great Neck, New York, 11021, United States
Retina-Vitreous Surgeons of Central New York
Liverpool, New York, 13088, United States
Vitreous Retina Macula Consultants of New York
New York, New York, 10022, United States
Retina Consultants PLLC
Slingerlands, New York, 12159, United States
Opthalmic Consultants of the Capital Region
Troy, New York, 12180, United States
Asheville Eye Associates - Western Carolina Retinal Associates
Asheville, North Carolina, 28803, United States
Duke University
Durham, North Carolina, 27705-4699, 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
Cleveland, Ohio, 44195, United States
Verum Research LLC
Eugene, Oregon, 97401, United States
Casey Eye Institute
Portland, Oregon, 97239, 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
Charles Retina Institute
Germantown, Tennessee, 38138, United States
Retina Research Institute of Texas
Abilene, Texas, 79606, United States
Panhandle Eye Group LLP-Southwest Retina Specialists
Amarillo, Texas, 79106, United States
Austin Clinical Research
Austin, Texas, 78750, United States
Retina and Vitreous of Texas, PLLC
Bellaire, Texas, 77401, United States
Retina Consultants of Texas 2
Bellaire, Texas, 77401, United States
Retina Foundation of the Southwest
Dallas, Texas, 75231, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
UT Southwestern
Dallas, Texas, 75390, United States
Texas Retina Associates 1
Fort Worth, Texas, 76104, United States
Houston Eye Associates
Houston, Texas, 77025, United States
San Antonio Eye Center
San Antonio, Texas, 78215, United States
Retina Associates Of South Texas P A
San Antonio, Texas, 78240, United States
Retina Consultants of Texas
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
Retina Associates of Utah P C
Salt Lake City, Utah, 84107, United States
Rocky Mountain Retina Consultants
Salt Lake City, Utah, 84107, 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
Adelaide Eye and Retina Centre
Adelaide, 5000, Australia
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
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liège, 4000, Belgium
Calgary Retina Consultants
Calgary, Alberta, T2H 0C8, Canada
Alberta Retina Consultants
Edmonton, Alberta, T5H 0X5, Canada
The Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6, Canada
The Retina Centre of Ottawa
Ottawa, Ontario, K2B 7E9, Canada
Institut De L'oeil Des Laurentides
Boisbriand, Quebec, J7H 0E8, Canada
OFTEX Ltd. - EYE CENTER
Pardubice, 530 02, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
AXON Clinical s.r.o.
Prague, 15000, Czechia
Aalborg University Hospital
Aalborg, 9000, Denmark
University Hospital Of Copenhagen, Glostrup Hospital
Glostrup Municipality, 2600, Denmark
Zealand University Hospital
Roskilde, 4000, Denmark
Charite Universitaetsmedizin Berlin
Berlin, 12203, Germany
Universitaets-Augenklinik Bonn
Bonn, 53127, Germany
Universitatsklinikum Gießen - Klinik und Poliklinik fur Augenheilkunde
Giessen, 35392, Germany
Klinikum Gottingen der Georg August Universitat
Göttingen, 37075, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitatsklinikum Schleswig Holstein Kiel
Kiel, 24105, Germany
Universitaetsklinikum Leipzig
Leipzig, 04103, Germany
Klinikum Ludwigshafen
Ludwigshafen am Rhein, 67063, Germany
Augenzentrum am St Franziskus Hospital Munster
Münster, 48145, Germany
Universitaetsklinikum Muenster
Münster, 48149, Germany
Universitaetsklinikum Tuebingen
Tübingen, 72076, Germany
Eszak Pesti Centrumkorhaz Honvedkorhaz
Budapest, 1062, Hungary
Ganglion Orvosi Központ
Pécs, 7621, Hungary
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg, 8900, Hungary
Arcispedale S. Anna Ferrara
Ferrara, 44124, Italy
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
Milan, 20122, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Sacco Hospital
Milan, 20157, Italy
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
Naples, 80138, Italy
Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Amsterdam University Medical Centers Location Academic Medical Center
Amsterdam, 1105 AZ, Netherlands
Radboudumc
Nijmegen, 6525 GA, Netherlands
Het Oogziekenhuis Rotterdam
Rotterdam, 3011, Netherlands
Oculomedica
Bydgoszcz, 85 157, Poland
Oftalmika
Bydgoszcz, 85 631, Poland
Uno Med
Tarnów, 33 100, 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 - Hosp. 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
Hosp. Dos de Maig
Barcelona, 08025, Spain
Inst. de Microcirugia Ocular
Barcelona, 08035, Spain
Clinica Oftalvist Valencia
Burjassot, 46100, Spain
Hosp. La Arruzafa
Córdoba, 14012, Spain
Hosp. Univ. Donostia
Donostia / San Sebastian, 20014, 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. Prov. Do Conxo
Santiago de Compostela, 15706, Spain
Hosp. Virgen Del Rocio
Seville, 41013, Spain
Hosp. Clinico Univ. Lozano Blesa
Zaragoza, 50009, Spain
Hosp. Univ. Miguel Servet
Zaragoza, 50009, Spain
S:t Eriks Ogonsjukhus
Stockholm, 171 64, Sweden
Inselspital Universitatsspital Bern
Bern, 3010, Switzerland
Hacettepe University Hospital
Ankara, 06230, Turkey (Türkiye)
Baskent University Ankara Hospital
Ankara, 06490, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
Dokuz Eylul University Hospital
Izmir, 35330, Turkey (Türkiye)
Konya Selcuk University Medical Faculty
Konya, 42250, Turkey (Türkiye)
Bristol Eye Hospital
Bristol, BS1 2LX, United Kingdom
Moorfields Eye Hospital
London, EC1V 2PD, United Kingdom
Central Middlesex Hospital
London, NW10 7NS, United Kingdom
The Retina Clinic London
London, W1G 9AX, United Kingdom
Manchester Royal Eye Hospital
Manchester, M13 9WL, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
Oxford Eye Hospital
Oxford, OX3 9DU, United Kingdom
Southampton University Hospital
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
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
March 7, 2023
First Posted
April 13, 2023
Study Start
March 6, 2023
Primary Completion
February 23, 2026
Study Completion
February 23, 2026
Last Updated
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.innovativemedicine.jnj.com/our-innovation/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