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)

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.

Study Overview

• Status: Completed
• Conditions: Geographic Atrophy
• Intervention / Treatment: Drug: JNJ-81201887; Drug: Prednisone; Drug: Triamcinolone; Other: Placebo; Other: Sham Procedure

• Study Type: Interventional
• Enrollment (Actual): 305
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • Adelaide Eye and Retina Centre
  • East Melbourne, Australia, 3002
    • Centre for Eye Research Australia
  • Strathfield, Australia, 2135
    • Strathfield Retina Clinic
  • Sydney, Australia, 2000
    • Sydney Retina Clinic and Day Surgery
  • Westmead, Australia, 2145
    • Sydney West Retina
• Belgium
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg
  • Ghent, Belgium, 9000
    • UZ Gent
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg
  • Liège, Belgium, 4000
    • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2H 0C8
      • Calgary Retina Consultants
    • Edmonton, Alberta, Canada, T5H 0X5
      • Alberta Retina Consultants
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital Research Institute
    • Ottawa, Ontario, Canada, K2B 7E9
      • The Retina Centre of Ottawa
  • Quebec
    • Boisbriand, Quebec, Canada, J7H 0E8
      • Institut de L'Oeil des Laurentides
• Czechia
  • Pardubice, Czechia, 530 02
    • OFTEX Ltd. - EYE CENTER
  • Prague, Czechia, 15000
    • Axon Clinical s.r.o.
  • Prague, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University Hospital
  • Glostrup Municipality, Denmark, 2600
    • University Hospital Of Copenhagen, Glostrup Hospital
  • Roskilde, Denmark, 4000
    • Zealand University Hospital
• Germany
  • Berlin, Germany, 12203
    • Charite Universitaetsmedizin Berlin
  • Bonn, Germany, 53127
    • Universitaets-Augenklinik Bonn
  • Giessen, Germany, 35392
    • Universitatsklinikum Gießen - Klinik und Poliklinik fur Augenheilkunde
  • Göttingen, Germany, 37075
    • Klinikum Gottingen der Georg August Universitat
  • Hanover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Kiel, Germany, 24105
    • Universitatsklinikum Schleswig Holstein Kiel
  • Leipzig, Germany, 04103
    • Universitaetsklinikum Leipzig
  • Ludwigshafen am Rhein, Germany, 67063
    • Klinikum Ludwigshafen
  • Münster, Germany, 48149
    • Universitaetsklinikum Muenster
  • Münster, Germany, 48145
    • Augenzentrum am St Franziskus Hospital Munster
  • Tübingen, Germany, 72076
    • Universitaetsklinikum Tuebingen
• Hungary
  • Budapest, Hungary, 1062
    • Eszak Pesti Centrumkorhaz Honvedkorhaz
  • Pécs, Hungary, 7621
    • Ganglion Orvosi Központ
  • Zalaegerszeg, Hungary, 8900
    • Zala Megyei Szent Rafael Korhaz
• Italy
  • Ferrara, Italy, 44124
    • Arcispedale S. Anna Ferrara
  • Milan, Italy, 20132
    • Ospedale San Raffaele
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
  • Milan, Italy, 20157
    • Sacco Hospital
  • Napoli, Italy, 80138
    • Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
  • Roma, Italy, 00168
    • Policlinico Universitario Agostino Gemelli
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Amsterdam University Medical Centers Location Academic Medical Center
  • Nijmegen, Netherlands, 6525 GA
    • Radboudumc
  • Rotterdam, Netherlands, 3011
    • Het Oogziekenhuis Rotterdam
• Poland
  • Bydgoszcz, Poland, 85 157
    • Oculomedica
  • Bydgoszcz, Poland, 85 631
    • Oftalmika
  • Tarnów, Poland, 33 100
    • Uno Med
  • Warsaw, Poland, 01 258
    • Warszawski Szpital Okulistyczny
• Portugal
  • Coimbra, Portugal, 3030-163
    • Espaco Medico de Coimbra
  • Coimbra, Portugal, 3000 075
    • Uls Coimbra - Hosp. Univ. Coimbra
  • Porto, Portugal, 4200 319
    • Uls Sao Joao - Hosp. Sao Joao
• Spain
  • Barcelona, Spain, 08021
    • Centro de Oftalmologia Barraquer
  • Barcelona, Spain, 08022
    • Centro Medico Teknon S.L.
  • Barcelona, Spain, 08022
    • Inst. Cat. de Retina
  • Barcelona, Spain, 08025
    • Hosp. Dos de Maig
  • Barcelona, Spain, 08035
    • Inst. de Microcirugia Ocular
  • Burjassot, Spain, 46100
    • Clinica Oftalvist Valencia
  • Córdoba, Spain, 14012
    • Hosp. La Arruzafa
  • Donostia / San Sebastian, Spain, 20014
    • Hosp. Univ. Donostia
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28040
    • Hosp Univ Fund Jimenez Diaz
  • Madrid, Spain, 28046
    • Clinica Baviera Madrid Castellana
  • Majadahonda, Spain, 28222
    • Hosp. Univ. Pta. de Hierro Majadahonda
  • Pamplona, Spain, 31008
    • Clinica Univ. de Navarra
  • Sant Cugat del Vallès, Spain, 08195
    • Idc Salud Hosp. Gral. de Catalunya
  • Santiago de Compostela, Spain, 15706
    • Hosp. Prov. Do Conxo
  • Seville, Spain, 41013
    • Hosp. Virgen Del Rocio
  • Zaragoza, Spain, 50009
    • Hosp. Clinico Univ. Lozano Blesa
  • Zaragoza, Spain, 50009
    • Hosp. Univ. Miguel Servet
• Sweden
  • Stockholm, Sweden, 171 64
    • S:t Eriks Ogonsjukhus
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Universitätsspital Bern
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06230
    • Hacettepe University Hospital
  • Ankara, Turkey (Türkiye), 06800
    • Ankara Bilkent Şehir Hastanesi
  • Ankara, Turkey (Türkiye), 06490
    • Baskent University Ankara Hospital
  • Izmir, Turkey (Türkiye), 35330
    • Dokuz Eylul University Hospital
  • Konya, Turkey (Türkiye), 42250
    • Konya Selcuk University Medical Faculty
• United Kingdom
  • Bristol, United Kingdom, BS1 2LX
    • Bristol Eye Hospital
  • London, United Kingdom, EC1V 2PD
    • Moorfields Eye Hospital
  • London, United Kingdom, NW10 7NS
    • Central Middlesex Hospital
  • London, United Kingdom, W1G 9AX
    • The Retina Clinic London
  • Manchester, United Kingdom, M13 9WL
    • Manchester Royal Eye Hospital
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Royal Victoria Infirmary
  • Oxford, United Kingdom, OX3 9DU
    • Oxford Eye Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton University Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Retinal Research Institute
    • Tucson, Arizona, United States, 85704
      • Retina Associates Southwest PC
  • California
    • Fullerton, California, United States, 92835
      • Retina Consultants of Orange County
    • Huntington Beach, California, United States, 92647
      • Retina Associates of Southern California
    • La Jolla, California, United States, 92093 0946
      • Shiley Eye Institute Jacobs Retina Center
    • Los Angeles, California, United States, 90095
      • Jules Stein Eye Institute UCLA
    • Los Angeles, California, United States, 91436
      • The Retina Partners
    • Oxnard, California, United States, 93036
      • California Retina Consultants
    • Palo Alto, California, United States, 94303
      • Stanford Health Care
    • Pasadena, California, United States, 91107
      • California Eye Medical Specialists
    • Poway, California, United States, 92064
      • Retina Consultants San Diego
    • Redlands, California, United States, 92374
      • Retina Consultants of Southern California
    • Walnut Creek, California, United States, 94598
      • Bay Area Retina Associates
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Colorado Retina - Lakewood Clinic
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Retina Group of Florida
    • Fort Myers, Florida, United States, 33912
      • National Opthalmic Research Institute
    • Gainesville, Florida, United States, 32607
      • VitreoRetinal Associates, PA
    • Miami, Florida, United States, 33143
      • Medeye Associates
    • Pensacola, Florida, United States, 32503
      • Retina Specialty Institute
    • Plantation, Florida, United States, 33324
      • Fort Lauderdale Eye Institute
    • St. Petersburg, Florida, United States, 33711
      • Retina Vitreous Associates of Florida
    • Stuart, Florida, United States, 34994
      • East Florida Eye Institute
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Marietta Eye Clinic
    • Marietta, Georgia, United States, 30060
      • Georgia Retina
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois
    • Elmhurst, Illinois, United States, 60126
      • Retina Associates
    • Lemont, Illinois, United States, 60439
      • University Retina
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Midwest Eye Institute
  • Maine
    • Portland, Maine, United States, 04101
      • Maine Eye Center
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • The Retina Care Center
    • Baltimore, Maryland, United States, 21204
      • Retina Specialists
    • Chevy Chase, Maryland, United States, 20815
      • The Retina Group of Washington
    • Hagerstown, Maryland, United States, 21740
      • Cumberland Valley Retina Consultants
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston
    • Worcester, Massachusetts, United States, 01605
      • Vitreo Retinal Associates-Worcester
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Foundation for Vision Research
    • Royal Oak, Michigan, United States, 48073
      • Associated Retinal Consultants P.C.
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Retina Consultants of Minnesota
  • Missouri
    • St Louis, Missouri, United States, 63144
      • The Retina Institute
  • Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08034
      • Wills Eye/Mid Atlantic Retina
  • New York
    • Great Neck, New York, United States, 11021
      • Long Island Vitreo Retinal Consultants
    • Liverpool, New York, United States, 13088
      • Retina-Vitreous Surgeons of Central New York
    • New York, New York, United States, 10022
      • Vitreous Retina Macula Consultants of New York
    • Slingerlands, New York, United States, 12159
      • Retina Consultants PLLC
    • Troy, New York, United States, 12180
      • Opthalmic Consultants of the Capital Region
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Eye Associates - Western Carolina Retinal Associates
    • Durham, North Carolina, United States, 27705-4699
      • Duke University
    • Hickory, North Carolina, United States, 28602
      • Graystone Eye
    • Wake Forest, North Carolina, United States, 27587
      • NC Retina Associates
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Eye Institute
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Verum Research LLC
    • Portland, Oregon, United States, 97239
      • Casey Eye Institute
    • Springfield, Oregon, United States, 97477
      • Cascade Medical Research Institute, LLC
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16505
      • Erie Retina Research
  • South Carolina
    • Beaufort, South Carolina, United States, 29902
      • Charleston Neuroscience Institute, LLC
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Charles Retina Institute
  • Texas
    • Abilene, Texas, United States, 79606
      • Retina Research Institute of Texas
    • Amarillo, Texas, United States, 79106
      • Panhandle Eye Group LLP-Southwest Retina Specialists
    • Austin, Texas, United States, 78750
      • Austin Clinical Research
    • Bellaire, Texas, United States, 77401
      • Retina and Vitreous of Texas, PLLC
    • Bellaire, Texas, United States, 77401
      • Retina Consultants of Texas 2
    • Dallas, Texas, United States, 75390
      • UT Southwestern
    • Dallas, Texas, United States, 75231
      • Texas Retina Associates
    • Dallas, Texas, United States, 75231
      • Retina Foundation of the Southwest
    • Fort Worth, Texas, United States, 76104
      • Texas Retina Associates 1
    • Houston, Texas, United States, 77025
      • Houston Eye Associates
    • San Antonio, Texas, United States, 78215
      • San Antonio Eye Center
    • San Antonio, Texas, United States, 78240
      • Retina Consultants of Texas
    • San Antonio, Texas, United States, 78240
      • Retina Associates Of South Texas P A
    • The Woodlands, Texas, United States, 77384
      • Retina Consultants of Texas
    • Willow Park, Texas, United States, 76087
      • Strategic Clinical Research Group
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah
    • Salt Lake City, Utah, United States, 84107
      • Rocky Mountain Retina Consultants
    • Salt Lake City, Utah, United States, 84107
      • Retina Associates of Utah P C
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Piedmont Eye Center
    • Norfolk, Virginia, United States, 23502
      • Wagner Kapoor Research institute
  • Washington
    • Spokane, Washington, United States, 99204
      • Spokane Eye Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: JNJ-81201887 Low Dose; Participants 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.	Drug: JNJ-81201887; JNJ-81201887 will be administered as intravitreal injection.; Other Names: AAVCAGsCD59; Drug: Prednisone; Prednisone will be administered as oral capsule.; Drug: Triamcinolone; Triamcinolone (corticosteroid injection) periocular injection will be administered as per local practice.
Experimental: Arm B: JNJ-81201887 High dose; Participants 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.	Drug: JNJ-81201887; JNJ-81201887 will be administered as intravitreal injection.; Other Names: AAVCAGsCD59; Drug: Prednisone; Prednisone will be administered as oral capsule.; Drug: Triamcinolone; Triamcinolone (corticosteroid injection) periocular injection will be administered as per local practice.
Sham Comparator: Arm C: Sham Procedure; Participants 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.	Other: Placebo; Prednisone matching placebo will be administered as oral capsule.; Other: Sham Procedure; Sham injections matching to single JNJ-81201887 injection and matching to corticosteroid (triamcinolone) periocular injection will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Low Luminance Visual Acuity (LLVA) at Month 18	Best corrected LLVA will be assessed using the early treatment diabetic retinopathy study (ETDRS) chart at a starting distance of 4 meter.	Baseline and Month 18
Change From Baseline in Reading Speed at Month 18	Change from baseline in reading speed (normal luminance) as assessed by Radner reading charts will be performed in the study eye and binocularly for participants who are fluent in the languages available for the Radner Chart will be reported.	Baseline and Month 18
Change From Baseline in Retinal Sensitivity by Mesopic Microperimetry (MAIA) at Month 18	Change from baseline retinal sensitivity by MAIA will be reported.	Baseline and Month 18
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 18	Change from baseline in BCVA will be reported and this will be measured using the ETDRS chart at a starting distance of 4 meter.	Baseline and Month 18
Change From Baseline in Functional Reading Independence (FRI) Index at Month 18	The FRI is an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. Item scores reflect decreasing levels of functional reading independence. The FRI Index yields continuous mean scores (range 1 to 4), and ordinal-level scores from Level 1 = "Unable to do" to Level 4 = "Totally independent." For each FRI Index reading activity performed in the past 7 days, participants are asked about the extent to which they required vision aids, adjustments in the activity, or help from another person.	Baseline and Month 18
Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at Month 18	The 2000 version of the NEI-VFQ-25, which must be interviewer-administered, includes 25 items and is scored to produce 11 subscales and a general health item. The 11 subscales include General Vision (1 item), Ocular Pain (2 items), Near Activities (3 items), Distance Activities (3 items), Social Functioning (2 items), Mental Health (2 items), Role Difficulties (2 items), Dependency (3 items), Driving (3 items), Color Vision (1 item), and Peripheral Vision (1 item). Response to each question converted to 0-100 score. Each subscale, total score equal to (=) average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score equal to less symptoms/better visual functioning.	Baseline and Month 18

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Actual): February 23, 2026
• Study Completion (Actual): February 23, 2026

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Macular Degeneration
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Geographic Atrophy; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienediols; Prednisone; Triamcinolone
• Other Study ID Numbers: CR109236; 81201887MDG2001 (Other Identifier: Janssen Research & Development, LLC); 2022-500746-16-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No