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Geographic AtrophyPhase 2NCT05811351

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 2 study testing JNJ-81201887, Prednisone and Triamcinolone in people with Geographic Atrophy, run by Janssen Research & Development, LLC at 162 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Geographic Atrophy
What is being tested?
JNJ-81201887, Prednisone and Triamcinolone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
305 participants
Where
162 sitesin 17 countries
Study dates
6 Mar 2023to 23 Feb 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

162 sites in 17 countries.

162 sites in 17 countries

United States79 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Panhandle Eye Group LLP-Southwest Retina Specialists

    Amarillo, Texas, 79106

  • Asheville Eye Associates - Western Carolina Retinal Associates

    Asheville, North Carolina, 28803

  • Austin Clinical Research

    Austin, Texas, 78750

  • Retina Specialists

    Baltimore, Maryland, 21204

  • The Retina Care Center

    Baltimore, Maryland, 21209

  • Charleston Neuroscience Institute, LLC

    Beaufort, South Carolina, 29902

  • Retina and Vitreous of Texas, PLLC

    Bellaire, Texas, 77401

  • Retina Consultants of Texas 2

    Bellaire, Texas, 77401

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Midwest Eye Institute

    Carmel, Indiana, 46032

  • Wills Eye/Mid Atlantic Retina

    Cherry Hill, New Jersey, 08034

  • The Retina Group of Washington

    Chevy Chase, Maryland, 20815

  • University Of Illinois

    Chicago, Illinois, 60612

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Retina Foundation of the Southwest

    Dallas, Texas, 75231

  • Texas Retina Associates

    Dallas, Texas, 75231

  • UT Southwestern

    Dallas, Texas, 75390

  • Duke University

    Durham, North Carolina, 27705-4699

  • Retina Associates

    Elmhurst, Illinois, 60126

  • Erie Retina Research

    Erie, Pennsylvania, 16505

  • Verum Research LLC

    Eugene, Oregon, 97401

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308

  • National Opthalmic Research Institute

    Fort Myers, Florida, 33912

  • Texas Retina Associates 1

    Fort Worth, Texas, 76104

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • VitreoRetinal Associates, PA

    Gainesville, Florida, 32607

  • Charles Retina Institute

    Germantown, Tennessee, 38138

  • Foundation for Vision Research

    Grand Rapids, Michigan, 49546

  • Long Island Vitreo Retinal Consultants

    Great Neck, New York, 11021

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Graystone Eye

    Hickory, North Carolina, 28602

  • Houston Eye Associates

    Houston, Texas, 77025

  • Retina Associates Of Southern California

    Huntington Beach, California, 92647

  • Shiley Eye Institute Jacobs Retina Center

    La Jolla, California, 92093 0946

  • Colorado Retina - Lakewood Clinic

    Lakewood, Colorado, 80228

  • University Retina

    Lemont, Illinois, 60439

  • Retina-Vitreous Surgeons of Central New York

    Liverpool, New York, 13088

  • Jules Stein Eye Institute UCLA

    Los Angeles, California, 90095

  • The Retina Partners

    Los Angeles, California, 91436

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502

  • Georgia Retina

    Marietta, Georgia, 30060

  • Marietta Eye Clinic

    Marietta, Georgia, 30060

  • MedEye Associates

    Miami, Florida, 33143

  • Vitreous Retina Macula Consultants of New York

    New York, New York, 10022

  • Wagner Kapoor Research institute

    Norfolk, Virginia, 23502

  • California Retina Consultants

    Oxnard, California, 93036

  • Stanford Health Care

    Palo Alto, California, 94303

  • California Eye Medical Specialists

    Pasadena, California, 91107

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Retinal Research Institute

    Phoenix, Arizona, 85053

  • Fort Lauderdale Eye Institute

    Plantation, Florida, 33324

  • Maine Eye Center

    Portland, Maine, 04101

  • Casey Eye Institute

    Portland, Oregon, 97239

  • Retina Consultants San Diego

    Poway, California, 92064

  • Retina Consultants of Southern California

    Redlands, California, 92374

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Associated Retinal Consultants P.C.

    Royal Oak, Michigan, 48073

  • Retina Consultants of Minnesota

    Saint Louis Park, Minnesota, 55416

  • Retina Associates of Utah P C

    Salt Lake City, Utah, 84107

  • Rocky Mountain Retina Consultants

    Salt Lake City, Utah, 84107

  • University of Utah

    Salt Lake City, Utah, 84132

  • San Antonio Eye Center

    San Antonio, Texas, 78215

  • Retina Associates Of South Texas P A

    San Antonio, Texas, 78240

  • Retina Consultants of Texas

    San Antonio, Texas, 78240

  • Retina Consultants PLLC

    Slingerlands, New York, 12159

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204

  • Cascade Medical Research Institute, LLC

    Springfield, Oregon, 97477

  • The Retina Institute

    St Louis, Missouri, 63144

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida, 33711

  • East Florida Eye Institute

    Stuart, Florida, 34994

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384

  • Opthalmic Consultants of the Capital Region

    Troy, New York, 12180

  • Retina Associates Southwest PC

    Tucson, Arizona, 85704

  • NC Retina Associates

    Wake Forest, North Carolina, 27587

  • Bay Area Retina Associates

    Walnut Creek, California, 94598

  • Strategic Clinical Research Group

    Willow Park, Texas, 76087

  • Vitreo Retinal Associates-Worcester

    Worcester, Massachusetts, 01605

Other trials in United States

Spain18 sites

  • Centro de Oftalmologia Barraquer

    Barcelona, 08021

  • Centro Medico Teknon S.L.

    Barcelona, 08022

  • Inst. Cat. de Retina

    Barcelona, 08022

  • Hosp. Dos de Maig

    Barcelona, 08025

  • Inst. de Microcirugia Ocular

    Barcelona, 08035

  • Clinica Oftalvist Valencia

    Burjassot, 46100

  • Hosp. La Arruzafa

    Córdoba, 14012

  • Hosp. Univ. Donostia

    Donostia / San Sebastian, 20014

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Clinica Baviera Madrid Castellana

    Madrid, 28046

  • Hosp. Univ. Pta. de Hierro Majadahonda

    Majadahonda, 28222

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Idc Salud Hosp. Gral. de Catalunya

    Sant Cugat del Vallès, 08195

  • Hosp. Prov. Do Conxo

    Santiago de Compostela, 15706

  • Hosp. Virgen Del Rocio

    Seville, 41013

  • Hosp. Clinico Univ. Lozano Blesa

    Zaragoza, 50009

  • Hosp. Univ. Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Germany11 sites

  • Charite Universitaetsmedizin Berlin

    Berlin, 12203

  • Universitaets-Augenklinik Bonn

    Bonn, 53127

  • Universitatsklinikum Gießen - Klinik und Poliklinik fur Augenheilkunde

    Giessen, 35392

  • Klinikum Gottingen der Georg August Universitat

    Göttingen, 37075

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitatsklinikum Schleswig Holstein Kiel

    Kiel, 24105

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

  • Klinikum Ludwigshafen

    Ludwigshafen am Rhein, 67063

  • Augenzentrum am St Franziskus Hospital Munster

    Münster, 48145

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

Other trials in Germany

United Kingdom8 sites

  • Bristol Eye Hospital

    Bristol, BS1 2LX

  • Moorfields Eye Hospital

    London, EC1V 2PD

  • Central Middlesex Hospital

    London, NW10 7NS

  • The Retina Clinic London

    London, W1G 9AX

  • Manchester Royal Eye Hospital

    Manchester, M13 9WL

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • Oxford Eye Hospital

    Oxford, OX3 9DU

  • Southampton University Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

Italy6 sites

  • Arcispedale S. Anna Ferrara

    Ferrara, 44124

  • Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano

    Milan, 20122

  • Ospedale San Raffaele

    Milan, 20132

  • Sacco Hospital

    Milan, 20157

  • Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli

    Naples, 80138

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168

Other trials in Italy

Australia5 sites

  • Adelaide Eye and Retina Centre

    Adelaide, 5000

  • Centre for Eye Research Australia

    East Melbourne, 3002

  • Strathfield Retina Clinic

    Strathfield, 2135

  • Sydney Retina Clinic and Day Surgery

    Sydney, 2000

  • Sydney West Retina

    Westmead, 2145

Other trials in Australia

Canada5 sites

  • Institut De L'oeil Des Laurentides

    Boisbriand, Quebec, J7H 0E8

  • Calgary Retina Consultants

    Calgary, Alberta, T2H 0C8

  • Alberta Retina Consultants

    Edmonton, Alberta, T5H 0X5

  • The Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

  • The Retina Centre of Ottawa

    Ottawa, Ontario, K2B 7E9

Other trials in Canada

Turkey (Türkiye)5 sites

  • Hacettepe University Hospital

    Ankara, 06230

  • Baskent University Ankara Hospital

    Ankara, 06490

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800

  • Dokuz Eylul University Hospital

    Izmir, 35330

  • Konya Selcuk University Medical Faculty

    Konya, 42250

Other trials in Turkey (Türkiye)

Belgium4 sites

  • Ziekenhuis Oost-Limburg

    Genk, 3600

  • UZ Gent

    Ghent, 9000

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

    Liège, 4000

Other trials in Belgium

Poland4 sites

  • Oculomedica

    Bydgoszcz, 85 157

  • Oftalmika

    Bydgoszcz, 85 631

  • Uno Med

    Tarnów, 33 100

  • Warszawski Szpital Okulistyczny

    Warsaw, 01 258

Other trials in Poland

Czechia3 sites

  • OFTEX Ltd. - EYE CENTER

    Pardubice, 530 02

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • AXON Clinical s.r.o.

    Prague, 15000

Other trials in Czechia

Denmark3 sites

  • Aalborg University Hospital

    Aalborg, 9000

  • University Hospital Of Copenhagen, Glostrup Hospital

    Glostrup Municipality, 2600

  • Zealand University Hospital

    Roskilde, 4000

Other trials in Denmark

Hungary3 sites

  • Eszak Pesti Centrumkorhaz Honvedkorhaz

    Budapest, 1062

  • Ganglion Orvosi Központ

    Pécs, 7621

  • Zala Megyei Szent Rafael Korhaz

    Zalaegerszeg, 8900

Other trials in Hungary

Netherlands3 sites

  • Amsterdam University Medical Centers Location Academic Medical Center

    Amsterdam, 1105 AZ

  • Radboudumc

    Nijmegen, 6525 GA

  • Het Oogziekenhuis Rotterdam

    Rotterdam, 3011

Other trials in Netherlands

Portugal3 sites

  • Uls Coimbra - Hosp. Univ. Coimbra

    Coimbra, 3000 075

  • Espaco Medico de Coimbra

    Coimbra, 3030-163

  • Uls Sao Joao - Hosp. Sao Joao

    Porto, 4200 319

Other trials in Portugal

Sweden1 site

  • S:t Eriks Ogonsjukhus

    Stockholm, 171 64

Other trials in Sweden

Switzerland1 site

  • Inselspital Universitatsspital Bern

    Bern, 3010

Other trials in Switzerland

About this study

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)

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.

Being tested
JNJ-81201887, Prednisone, Placebo, Triamcinolone, Sham Procedure
Keywords
Macular Degeneration
Medical subject headings
Geographic Atrophy, Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-81201887Drug

    Also called AAVCAGsCD59

    JNJ-81201887 will be administered as intravitreal injection.

  • PrednisoneDrug

    Prednisone will be administered as oral capsule.

  • PlaceboOther

    Prednisone matching placebo will be administered as oral capsule.

  • TriamcinoloneDrug

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

  • Sham ProcedureOther

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

Study groups in NCT05811351
Study groupRoleWhat they receive
Arm A: JNJ-81201887 Low DoseExperimentalParticipants 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.
Receives: Drug: JNJ-81201887; Drug: Prednisone; Drug: Triamcinolone
Arm B: JNJ-81201887 High doseExperimentalParticipants 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.
Receives: Drug: JNJ-81201887; Drug: Prednisone; Drug: Triamcinolone
Arm C: Sham ProcedureSham 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.
Receives: Other: Placebo; Other: Sham Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline and Month 18

  2. 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.

    Measured: Baseline to Month 18

Secondary outcomes (6)

  1. 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.

    Measured: Baseline and Month 18

  2. 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.

    Measured: Baseline and Month 18

  3. Change From Baseline in Retinal Sensitivity by Mesopic Microperimetry (MAIA) at Month 18

    Change from baseline retinal sensitivity by MAIA will be reported.

    Measured: Baseline and Month 18

  4. 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.

    Measured: Baseline and Month 18

  5. 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.

    Measured: Baseline and Month 18

  6. 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.

    Measured: Baseline and Month 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2023
  2. Study start6 Mar 2023
  3. Primary completion23 Feb 2026
  4. Study completion23 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05811351
Sponsor's protocol ID
CR109236
Other IDs
81201887MDG2001, 2022-500746-16-00
Status last verified
Mar 2026
First submitted
7 Mar 2023
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-81201887, Prednisone and Triamcinolone in people with Geographic Atrophy, run by Janssen Research & Development, LLC at 162 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 162 sites in United States, Spain, Germany, United Kingdom, Italy and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global: Change From Baseline in Square Root of Geographic Atrophy (GA) Lesion Area in the Study Eye at Month 18 (time frame: Baseline and Month 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05811351.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

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