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)

Geographic Atrophy Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05811351
• Other study ID #: CR109236
• Secondary ID: 81201887MDG20012
• Status: Recruiting
• Phase: Phase 2
• Start date: March 6, 2023
• Est. completion date: January 8, 2026

Study information

• Verified date: May 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 8, 2026
• Est. primary completion date: July 16, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy
• Macular Degeneration

Intervention

Drug:
• JNJ-81201887
JNJ-81201887 will be administered as intravitreal injection.
• Prednisone
Prednisone will be administered as oral capsule.

Other:
• Placebo
Prednisone matching placebo will be administered as oral capsule.

Drug:
• Triamcinolone
Triamcinolone (corticosteroid injection) periocular injection will be administered as per local practice.

Other:
• Sham Procedure
Sham injections matching to single JNJ-81201887 injection and matching to corticosteroid (triamcinolone) periocular injection will be administered.

Locations

Country	Name	City	State
Australia	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
Belgium	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
Canada	Institut De L'oeil Des Laurentides	Boisbriand	Quebec
Canada	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
Czechia	OFTEX Ltd. - EYE CENTER	Pardubice
Czechia	AXON Clinical s.r.o.	Prague
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha 10
Denmark	Aalborg University Hospital	Aalborg
Denmark	University Hospital Of Copenhagen, Glostrup Hospital	Glostrup
Denmark	Zealand University Hospital	Roskilde
Germany	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	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
Hungary	Eszak Pesti Centrumkorhaz Honvedkorhaz	Budapest
Hungary	Ganglion Orvosi Központ	Pecs
Hungary	Zala Megyei Szent Rafael Korhaz	Zalaegerszeg
Italy	Arcispedale S. Anna Ferrara	Ferrara
Italy	Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano	Milano
Italy	Ospedale San Raffaele	Milano
Italy	Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli	Napoli
Italy	Policlinico Universitario Agostino Gemelli	Roma
Netherlands	Amsterdam University Medical Centers Location Academic Medical Center	Amsterdam
Netherlands	Radboudumc	Nijmegen
Netherlands	Het Oogziekenhuis Rotterdam	Rotterdam
Poland	Klinika Okulistyczna OFTALMIKA	Bydgoszcz
Poland	Oculomedica, Specjalistyczny Osrodek Okulistyczny	Bydgoszcz
Poland	Uno-Med	Tarnow
Poland	Warszawski Szpital Okulistyczny	Warszawa
Portugal	Chuc - Hosp. Da Univ. de Coimbra	Coimbra
Portugal	Espaço Médico de Coimbra	Coimbra
Portugal	Chsj - Hosp. Sao Joao	Porto
Spain	Centro de Oftalmologia Barraquer	Barcelona
Spain	Centro Medico Teknon S.L.	Barcelona
Spain	Hosp. Dos de Maig	Barcelona
Spain	Inst. Cat. de Retina	Barcelona
Spain	Inst. de Microcirugia Ocular	Barcelona
Spain	Clinica Oftalvist Valencia	Burjassot
Spain	Hosp. La Arruzafa	Cordoba
Spain	Clinica Baviera Madrid Castellana	Madrid
Spain	Hosp. Univ. 12 de Octubre	Madrid
Spain	Hosp. Univ. Fund. Jimenez Diaz	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
Sweden	S:t Eriks Ogonsjukhus	Stockholm
Switzerland	INSELSPITAL Universitatsspital Bern	Bern
Turkey	Ankara Bilkent Sehir Hastanesi	Ankara
Turkey	Baskent University Ankara Hospital	Ankara
Turkey	Hacettepe University Hospital	Ankara
Turkey	Dokuz Eylul University Hospital	Izmir
Turkey	Konya Selcuk University Medical Faculty	Konya
United Kingdom	Bristol Eye Hospital	Bristol
United Kingdom	Central Middlesex Hospital	London
United Kingdom	Moorfields Eye Hospital	London
United Kingdom	The Retina Clinic London	London
United Kingdom	Royal Victoria Infirmary	Newcastle upon Tyne
United Kingdom	Oxford Eye Hospital	Oxford
United Kingdom	Southampton University Hospital	Southampton
United States	Retina Research Institute of Texas	Abilene	Texas
United States	Panhandle Eye Group LLP-Southwest Retina Specialists	Amarillo	Texas
United States	Asheville Eye Associates - Western Carolina Retinal Associates	Asheville	North Carolina
United States	Austin Clinical Research	Austin	Texas
United States	Retina Specialty Institute	Baltimore	Maryland
United States	The Retina Care Center	Baltimore	Maryland
United States	Charleston Neuroscience Institute, LLC	Beaufort	South Carolina
United States	Retina and Vitreous of Texas, PLLC	Bellaire	Texas
United States	Retina Consultants of Texas	Bellaire	Texas
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Midwest Eye Institute	Carmel	Indiana
United States	Wills Eye/Mid Atlantic Retina	Cherry Hill	New Jersey
United States	The Retina Group of Washington	Chevy Chase	Maryland
United States	University Of Illinois	Chicago	Illinois
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Retina Foundation of the Southwest	Dallas	Texas
United States	Texas Retina Associates	Dallas	Texas
United States	UT Southwestern	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	Retina Associates	Elmhurst	Illinois
United States	Erie Retina Research	Erie	Pennsylvania
United States	Verum Research LLC	Eugene	Oregon
United States	Retina Group of Florida	Fort Lauderdale	Florida
United States	National Opthalmic Research Institute	Fort Myers	Florida
United States	Texas Retina Associates	Fort Worth	Texas
United States	Retina Consultants of Orange County	Fullerton	California
United States	VitreoRetinal Associates, PA	Gainesville	Florida
United States	Charles Retina Institute	Germantown	Tennessee
United States	Foundation for Vision Research	Grand Rapids	Michigan
United States	Long Island Vitreo Retinal Consultants	Great Neck	New York
United States	Cumberland Valley Retina Consultants	Hagerstown	Maryland
United States	Graystone Eye	Hickory	North Carolina
United States	Houston Eye Associates	Houston	Texas
United States	Retina Associates Of Southern California	Huntington Beach	California
United States	Shiley Eye Institute Jacobs Retina Center	La Jolla	California
United States	Colorado Retina - Lakewood Clinic	Lakewood	Colorado
United States	University Retina	Lemont	Illinois
United States	Retina-Vitreous Surgeons of Central New York	Liverpool	New York
United States	Jules Stein Eye Institute UCLA	Los Angeles	California
United States	The Retina Partners	Los Angeles	California
United States	Piedmont Eye Center	Lynchburg	Virginia
United States	Georgia Retina	Marietta	Georgia
United States	Marietta Eye Clinic	Marietta	Georgia
United States	MedEye Associates	Miami	Florida
United States	Vitreous Retina Macula Consultants of New York	New York	New York
United States	Wagner Kapoor Research institute	Norfolk	Virginia
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 Specialty Institute	Pensacola	Florida
United States	Retinal Research Institute	Phoenix	Arizona
United States	Fort Lauderdale Eye Institute	Plantation	Florida
United States	Casey Eye Institute	Portland	Oregon
United States	Maine Eye Center	Portland	Maine
United States	Retina Consultants San Diego	Poway	California
United States	Retina Consultants of Southern California	Redlands	California
United States	Sierra Eye Associates	Reno	Nevada
United States	Associated Retinal Consultants P.C.	Royal Oak	Michigan
United States	The Retina Institute	Saint Louis	Missouri
United States	Retina Consultants of Minnesota	Saint Louis Park	Minnesota
United States	Retina Vitreous Associates of Florida	Saint Petersburg	Florida
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	Retina Associates Of South Texas P A	San Antonio	Texas
United States	Retina Consultants of Texas	San Antonio	Texas
United States	San Antonio Eye Center	San Antonio	Texas
United States	Retina Consultants PLLC	Slingerlands	New York
United States	Spokane Eye Clinical Research	Spokane	Washington
United States	Cascade Medical Research Institute, LLC	Springfield	Oregon
United States	East Florida Eye Institute	Stuart	Florida
United States	Retina Consultants of Texas	The Woodlands	Texas
United States	Opthalmic Consultants of the Capital Region	Troy	New York
United States	Retina Associates Southwest PC	Tucson	Arizona
United States	NC Retina Associates	Wake Forest	North Carolina
United States	Bay Area Retina Associates	Walnut Creek	California
United States	Strategic Clinical Research Group	Willow Park	Texas
United States	Vitreo Retinal Associates-Worcester	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  Denmark,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Portugal,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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