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)
- Conditions
- Geographic Atrophy
- Interventions
- Registration Number
- NCT05811351
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 305
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: JNJ-81201887 Low Dose JNJ-81201887 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. Arm A: JNJ-81201887 Low Dose Prednisone 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. Arm A: JNJ-81201887 Low Dose Triamcinolone 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. Arm B: JNJ-81201887 High dose JNJ-81201887 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. Arm B: JNJ-81201887 High dose Prednisone 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. Arm B: JNJ-81201887 High dose Triamcinolone 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. Arm C: Sham Procedure Placebo 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. Arm C: Sham Procedure 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.
- Primary Outcome Measures
Name Time Method Global: Change From Baseline in Square Root of Geographic Atrophy (GA) Lesion Area in the Study Eye at Month 18 Baseline and 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).
United States (U.S.) Specific: Rate of Change in Untransformed GA Lesion Area in the Study Eye Baseline to Month 18 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Retinal Sensitivity by Mesopic Microperimetry (MAIA) at Month 18 Baseline and Month 18 Change from baseline retinal sensitivity by MAIA will be reported.
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 18 Baseline and 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.
Change From Baseline in Reading Speed at Month 18 Baseline and 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.
Change From Baseline in Low Luminance Visual Acuity (LLVA) at Month 18 Baseline and Month 18 Best corrected LLVA will be assessed using the early treatment diabetic retinopathy study (ETDRS) chart at a starting distance of 4 meter.
Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at Month 18 Baseline and 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.
Change From Baseline in Functional Reading Independence (FRI) Index at Month 18 Baseline and 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.
Trial Locations
- Locations (159)
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitatsklinikum Schleswig Holstein Kiel
🇩🇪Kiel, Germany
Universitaetsklinikum Leipzig
🇩🇪Leipzig, Germany
Klinikum Ludwigshafen
🇩🇪Ludwigshafen am Rhein, Germany
Augenzentrum am St Franziskus Hospital Munster
🇩🇪Muenster, Germany
Universitaetsklinikum Muenster
🇩🇪Muenster, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Eszak Pesti Centrumkorhaz Honvedkorhaz
ðŸ‡ðŸ‡ºBudapest, Hungary
Ganglion Orvosi Központ
ðŸ‡ðŸ‡ºPecs, Hungary
Zala Megyei Szent Rafael Korhaz
ðŸ‡ðŸ‡ºZalaegerszeg, Hungary
Arcispedale S. Anna Ferrara
🇮🇹Ferrara, Italy
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
🇮🇹Milano, Italy
Ospedale San Raffaele
🇮🇹Milano, Italy
Sacco Hospital
🇮🇹Milano, Italy
Baskent University Ankara Hospital
🇹🇷Ankara, Turkey
Ankara Bilkent Sehir Hastanesi
🇹🇷Ankara, Turkey
Dokuz Eylul University Hospital
🇹🇷İzmir, Turkey
Konya Selcuk University Medical Faculty
🇹🇷Konya, Turkey
Bristol Eye Hospital
🇬🇧Bristol, United Kingdom
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
🇮🇹Napoli, Italy
Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Italy
Amsterdam University Medical Centers Location Academic Medical Center
🇳🇱Amsterdam, Netherlands
Het Oogziekenhuis Rotterdam
🇳🇱Rotterdam, Netherlands
Oculomedica
🇵🇱Bydgoszcz, Poland
Oftalmika
🇵🇱Bydgoszcz, Poland
Uno Med
🇵🇱Tarnow, Poland
Warszawski Szpital Okulistyczny
🇵🇱Warszawa, Poland
Uls Coimbra - Hosp. Univ. Coimbra
🇵🇹Coimbra, Portugal
Espaco Medico de Coimbra
🇵🇹Coimbra, Portugal
Uls Sao Joao - Hosp. Sao Joao
🇵🇹Porto, Portugal
Centro de Oftalmologia Barraquer
🇪🇸Barcelona, Spain
Centro Medico Teknon S.L.
🇪🇸Barcelona, Spain
Inst. Cat. de Retina
🇪🇸Barcelona, Spain
Hosp. Dos de Maig
🇪🇸Barcelona, Spain
Inst. de Microcirugia Ocular
🇪🇸Barcelona, Spain
Clinica Oftalvist Valencia
🇪🇸Burjassot, Spain
Hosp. La Arruzafa
🇪🇸Cordoba, Spain
Hosp. Univ. Donostia
🇪🇸Donostia San Sebastian, Spain
Hosp Univ Fund Jimenez Diaz
🇪🇸Madrid, Spain
Hosp. Univ. 12 de Octubre
🇪🇸Madrid, Spain
Clinica Baviera Madrid Castellana
🇪🇸Madrid, Spain
Hosp. Univ. Pta. de Hierro Majadahonda
🇪🇸Majadahonda, Spain
Clinica Univ. de Navarra
🇪🇸Pamplona, Spain
Idc Salud Hosp. Gral. de Catalunya
🇪🇸Sant Cugat del Valles, Spain
Hosp. Prov. Do Conxo
🇪🇸Santiago de Compostela, Spain
Hosp. Virgen Del Rocio
🇪🇸Sevilla, Spain
Hosp. Clinico Univ. Lozano Blesa
🇪🇸Zaragoza, Spain
Hosp. Univ. Miguel Servet
🇪🇸Zaragoza, Spain
S:t Eriks Ogonsjukhus
🇸🇪Stockholm, Sweden
Inselspital Universitatsspital Bern
🇨ðŸ‡Bern, Switzerland
Hacettepe University Hospital
🇹🇷Ankara, Turkey
Moorfields Eye Hospital
🇬🇧London, United Kingdom
Central Middlesex Hospital
🇬🇧London, United Kingdom
The Retina Clinic London
🇬🇧London, United Kingdom
Manchester Royal Eye Hospital
🇬🇧Manchester, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle upon Tyne, United Kingdom
Oxford Eye Hospital
🇬🇧Oxford, United Kingdom
Southampton University Hospital
🇬🇧Southampton, United Kingdom
AXON Clinical s.r.o.
🇨🇿Prague, Czechia
Fakultni nemocnice Kralovske Vinohrady
🇨🇿Praha 10, Czechia
Retinal Research Institute
🇺🇸Phoenix, Arizona, United States
Retina Associates Southwest PC
🇺🇸Tucson, Arizona, United States
Retina Consultants of Orange County
🇺🇸Fullerton, California, United States
Retina Associates Of Southern California
🇺🇸Huntington Beach, California, United States
Shiley Eye Institute Jacobs Retina Center
🇺🇸La Jolla, California, United States
Jules Stein Eye Institute UCLA
🇺🇸Los Angeles, California, United States
The Retina Partners
🇺🇸Los Angeles, California, United States
California Retina Consultants
🇺🇸Oxnard, California, United States
Stanford Health Care
🇺🇸Palo Alto, California, United States
California Eye Medical Specialists
🇺🇸Pasadena, California, United States
Retina Consultants San Diego
🇺🇸Poway, California, United States
Retina Consultants of Southern California
🇺🇸Redlands, California, United States
Bay Area Retina Associates
🇺🇸Walnut Creek, California, United States
Colorado Retina - Lakewood Clinic
🇺🇸Lakewood, Colorado, United States
Retina Group of Florida
🇺🇸Fort Lauderdale, Florida, United States
National Opthalmic Research Institute
🇺🇸Fort Myers, Florida, United States
VitreoRetinal Associates, PA
🇺🇸Gainesville, Florida, United States
MedEye Associates
🇺🇸Miami, Florida, United States
Retina Specialty Institute
🇺🇸Pensacola, Florida, United States
Fort Lauderdale Eye Institute
🇺🇸Plantation, Florida, United States
Retina Vitreous Associates of Florida
🇺🇸Saint Petersburg, Florida, United States
East Florida Eye Institute
🇺🇸Stuart, Florida, United States
Georgia Retina
🇺🇸Marietta, Georgia, United States
Marietta Eye Clinic
🇺🇸Marietta, Georgia, United States
University Of Illinois
🇺🇸Chicago, Illinois, United States
Retina Associates
🇺🇸Elmhurst, Illinois, United States
University Retina
🇺🇸Lemont, Illinois, United States
Midwest Eye Institute
🇺🇸Carmel, Indiana, United States
Maine Eye Center
🇺🇸Portland, Maine, United States
Retina Specialists
🇺🇸Baltimore, Maryland, United States
The Retina Care Center
🇺🇸Baltimore, Maryland, United States
The Retina Group of Washington
🇺🇸Chevy Chase, Maryland, United States
Cumberland Valley Retina Consultants
🇺🇸Hagerstown, Maryland, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Vitreo Retinal Associates-Worcester
🇺🇸Worcester, Massachusetts, United States
Foundation for Vision Research
🇺🇸Grand Rapids, Michigan, United States
Associated Retinal Consultants P.C.
🇺🇸Royal Oak, Michigan, United States
Retina Consultants of Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
The Retina Institute
🇺🇸Saint Louis, Missouri, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Wills Eye/Mid Atlantic Retina
🇺🇸Cherry Hill, New Jersey, United States
Long Island Vitreo Retinal Consultants
🇺🇸Great Neck, New York, United States
Retina-Vitreous Surgeons of Central New York
🇺🇸Liverpool, New York, United States
Vitreous Retina Macula Consultants of New York
🇺🇸New York, New York, United States
Retina Consultants PLLC
🇺🇸Slingerlands, New York, United States
Opthalmic Consultants of the Capital Region
🇺🇸Troy, New York, United States
Asheville Eye Associates - Western Carolina Retinal Associates
🇺🇸Asheville, North Carolina, United States
Duke University
🇺🇸Durham, North Carolina, United States
Graystone Eye
🇺🇸Hickory, North Carolina, United States
NC Retina Associates
🇺🇸Wake Forest, North Carolina, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Verum Research LLC
🇺🇸Eugene, Oregon, United States
Casey Eye Institute
🇺🇸Portland, Oregon, United States
Cascade Medical Research Institute, LLC
🇺🇸Springfield, Oregon, United States
Erie Retina Research
🇺🇸Erie, Pennsylvania, United States
Charleston Neuroscience Institute, LLC
🇺🇸Beaufort, South Carolina, United States
Charles Retina Institute
🇺🇸Germantown, Tennessee, United States
Retina Research Institute of Texas
🇺🇸Abilene, Texas, United States
Panhandle Eye Group LLP-Southwest Retina Specialists
🇺🇸Amarillo, Texas, United States
Austin Clinical Research
🇺🇸Austin, Texas, United States
Retina and Vitreous of Texas, PLLC
🇺🇸Bellaire, Texas, United States
Retina Consultants of Texas
🇺🇸The Woodlands, Texas, United States
Retina Foundation of the Southwest
🇺🇸Dallas, Texas, United States
Texas Retina Associates
🇺🇸Fort Worth, Texas, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
San Antonio Eye Center
🇺🇸San Antonio, Texas, United States
Retina Associates Of South Texas P A
🇺🇸San Antonio, Texas, United States
Strategic Clinical Research Group
🇺🇸Willow Park, Texas, United States
Retina Associates of Utah P C
🇺🇸Salt Lake City, Utah, United States
Rocky Mountain Retina Consultants
🇺🇸Salt Lake City, Utah, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Piedmont Eye Center
🇺🇸Lynchburg, Virginia, United States
Wagner Kapoor Research institute
🇺🇸Norfolk, Virginia, United States
Spokane Eye Clinical Research
🇺🇸Spokane, Washington, United States
Adelaide Eye and Retina Centre
🇦🇺Adelaide, Australia
Centre for Eye Research Australia
🇦🇺East Melbourne, Australia
Strathfield Retina Clinic
🇦🇺Strathfield, Australia
Sydney Retina Clinic and Day Surgery
🇦🇺Sydney, Australia
Sydney West Retina
🇦🇺Westmead, Australia
Ziekenhuis Oost-Limburg
🇧🇪Genk, Belgium
UZ Gent
🇧🇪Gent, Belgium
UZ Leuven Gasthuisberg
🇧🇪Leuven, Belgium
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
🇧🇪Liege, Belgium
Calgary Retina Consultants
🇨🇦Calgary, Alberta, Canada
Alberta Retina Consultants
🇨🇦Edmonton, Alberta, Canada
The Ottawa Hospital Research Institute
🇨🇦Ottawa, Ontario, Canada
The Retina Centre of Ottawa
🇨🇦Ottawa, Ontario, Canada
Institut De L'oeil Des Laurentides
🇨🇦Boisbriand, Quebec, Canada
OFTEX Ltd. - EYE CENTER
🇨🇿Pardubice, Czechia
Aalborg University Hospital
🇩🇰Aalborg, Denmark
University Hospital Of Copenhagen, Glostrup Hospital
🇩🇰Glostrup, Denmark
Zealand University Hospital
🇩🇰Roskilde, Denmark
Charite Universitaetsmedizin Berlin
🇩🇪Berlin, Germany
Universitaets-Augenklinik Bonn
🇩🇪Bonn, Germany
Universitatsklinikum Gießen - Klinik und Poliklinik fur Augenheilkunde
🇩🇪Giessen, Germany
Klinikum Gottingen der Georg August Universitat
🇩🇪Gottingen, Germany
Radboudumc
🇳🇱Nijmegen, Netherlands