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Geographic AtrophyPhase 2/3NCT06635148

A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

A Phase 2/3 study testing JNJ-81201887 in people with Geographic Atrophy and Macular Degeneration, run by Janssen Research & Development, LLC at 104 sites in 18 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Geographic Atrophy, Macular Degeneration
What is being tested?
JNJ-81201887
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
274 participants
Where
104 sitesin 18 countries
Study dates
19 Sep 2024to 16 Jul 2030
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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

  • Participants who were enrolled and received treatment with JNJ-81201887 or sham in a parent clinical study (81201887MDG2001, 81201887MDG1003)
  • Females (women of childbearing potential), male participants, and partners of male participants will not be required to use contraception in this LTE study
  • Must sign an informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. The ICF may be signed by an impartial witness and/or legally designated representative depending on national/local regulations

Who cannot join

  • There are no exclusion criteria for this LTE study

Trial locations and contacts

104 sites in 18 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

104 sites in 18 countries

United States45 sites, 45 recruiting

  • Asheville Eye Associates - Western Carolina Retinal Associates

    Asheville, North Carolina, 28803

    Recruiting

  • Austin Clinical Research

    Austin, Texas, 78750

    Recruiting

  • Retina Specialists

    Baltimore, Maryland, 21204

    Recruiting

  • Charleston Neuroscience Institute, LLC

    Beaufort, South Carolina, 29902

    Recruiting

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

    Recruiting

  • Midwest Eye Institute

    Carmel, Indiana, 46032

    Recruiting

  • The Retina Group of Washington

    Chevy Chase, Maryland, 20815

    Recruiting

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242

    Recruiting

  • Cleveland Clinic Main Campus

    Cleveland, Ohio, 44195

    Recruiting

  • Texas Retina Associates

    Dallas, Texas, 75231

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

  • Duke Eye Center

    Durham, North Carolina, 27705

    Recruiting

  • Erie Retina Research

    Erie, Pennsylvania, 16505

    Recruiting

  • Verum Research LLC

    Eugene, Oregon, 97401

    Recruiting

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308

    Recruiting

  • Retina Consultants of Orange County

    Fullerton, California, 92835

    Recruiting

  • VitreoRetinal Associates, PA

    Gainesville, Florida, 32607

    Recruiting

  • Foundation for Vision Research

    Grand Rapids, Michigan, 49546

    Recruiting

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

    Recruiting

  • Graystone Eye

    Hickory, North Carolina, 28602

    Recruiting

  • Shiley Eye Institute Jacobs Retina Center

    La Jolla, California, 92093 0946

    Recruiting

  • University Retina

    Lemont, Illinois, 60439

    Recruiting

  • Retina-Vitreous Surgeons of Central New York

    Liverpool, New York, 13088

    Recruiting

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502

    Recruiting

  • Georgia Retina

    Marietta, Georgia, 30060

    Recruiting

  • Marietta Eye Clinic

    Marietta, Georgia, 30060

    Recruiting

  • Wagner Kapoor Research institute

    Norfolk, Virginia, 23502

    Recruiting

  • California Retina Consultants

    Oxnard, California, 93036

    Recruiting

  • California Eye Medical Specialists

    Pasadena, California, 91107

    Recruiting

  • Retina Specialty Institute

    Pensacola, Florida, 32503

    Recruiting

  • Maine Eye Center

    Portland, Maine, 04101

    Recruiting

  • Retina Consultants San Diego

    Poway, California, 92064

    Recruiting

  • Sierra Eye Associates

    Reno, Nevada, 89502

    Recruiting

  • Retina Consultants of Minnesota

    Saint Louis Park, Minnesota, 55416

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84132

    Recruiting

  • Retina Associates Of South Texas P A

    San Antonio, Texas, 78240

    Recruiting

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204

    Recruiting

  • Cascade Medical Research Institute, LLC

    Springfield, Oregon, 97477

    Recruiting

  • The Retina Institute

    St Louis, Missouri, 63128

    Recruiting

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida, 33711

    Recruiting

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384

    Recruiting

  • Retina Associates Southwest PC

    Tucson, Arizona, 85704

    Recruiting

  • NC Retina Associates

    Wake Forest, North Carolina, 27587

    Recruiting

  • Bay Area Retina Associates

    Walnut Creek, California, 94598

    Recruiting

  • Strategic Clinical Research Group

    Willow Park, Texas, 76087

    Recruiting

Other trials in United States

Spain13 sites, 13 recruiting

  • Centro de Oftalmologia Barraquer

    Barcelona, 08021

    Recruiting

  • Centro Medico Teknon S.L.

    Barcelona, 08022

    Recruiting

  • Inst. Cat. de Retina

    Barcelona, 08022

    Recruiting

  • Clinica Oftalvist Valencia

    Burjassot, 46100

    Recruiting

  • Hosp. La Arruzafa

    Córdoba, 14012

    Recruiting

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

    Recruiting

  • Clinica Baviera Madrid Castellana

    Madrid, 28046

    Recruiting

  • Hosp. Univ. Pta. de Hierro Majadahonda

    Majadahonda, 28222

    Recruiting

  • Clinica Univ. de Navarra

    Pamplona, 31008

    Recruiting

  • Idc Salud Hosp. Gral. de Catalunya

    Sant Cugat del Vallès, 08195

    Recruiting

  • Hosp. Virgen Del Rocio

    Seville, 41013

    Recruiting

  • Hosp. Clinico Univ. Lozano Blesa

    Zaragoza, 50009

    Recruiting

Other trials in Spain

Germany7 sites, 7 recruiting

  • Universitaets-Augenklinik Bonn

    Bonn, 53127

    Recruiting

  • Klinikum Gottingen der Georg August Universitat

    Göttingen, 37075

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, 30625

    Recruiting

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

    Recruiting

  • Klinikum Ludwigshafen

    Ludwigshafen am Rhein, 67063

    Recruiting

  • Augenzentrum am St Franziskus Hospital Munster

    Münster, 48145

    Recruiting

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

    Recruiting

Other trials in Germany

Italy6 sites, 6 recruiting

  • Azienda Ospedaliero Universitaria di Ferrara

    Ferrara, 44124

    Recruiting

  • ASST Fatebenefratelli Sacco

    Milan, 20157

    Recruiting

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

    Recruiting

  • IRCCS Ospedale San Raffaele

    Milan, 20132

    Recruiting

  • Azienda Ospedaliero Universitaria Luigi Vanvitelli

    Naples, 80138

    Recruiting

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168

    Recruiting

Other trials in Italy

Australia4 sites, 4 recruiting

  • Centre for Eye Research Australia

    East Melbourne, 3002

    Recruiting

  • Strathfield Retina Clinic

    Strathfield, 2135

    Recruiting

  • Sydney Retina Clinic and Day Surgery

    Sydney, 2000

    Recruiting

  • Sydney West Retina

    Westmead, 2145

    Recruiting

Other trials in Australia

United Kingdom4 sites

  • Bristol Eye Hospital

    Bristol, BS1 2LX

    Active, not recruiting

  • Oxford Eye Hospital

    Headington, OX3 9DU

    Active, not recruiting

  • The Retina Clinic London

    London, W1G 9AX

    Active, not recruiting

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

    Completed

Other trials in United Kingdom

Belgium3 sites

  • Ziekenhuis Oost-Limburg

    Genk, 3600

    Active, not recruiting

  • UZ Gent

    Ghent, 9000

    Active, not recruiting

  • UZ Leuven Gasthuisberg

    Leuven, 3000

    Active, not recruiting

Other trials in Belgium

China3 sites, 3 recruiting

  • Beijing Tongren Hospital CMU

    Beijing, 100730

    Recruiting

  • West China Hospital Si Chuan University

    Chengdu, 610041

    Recruiting

  • Shanghai General Hospital

    Shanghai, 200080

    Recruiting

Other trials in China

Hungary3 sites, 3 recruiting

  • Eszak Pesti Centrumkorhaz Honvedkorhaz

    Budapest, 1062

    Recruiting

  • Ganglion Orvosi Központ

    Pécs, 7621

    Recruiting

  • Zala Varmegyei Szent Rafael Korhaz

    Zalaegerszeg, 8900

    Recruiting

Other trials in Hungary

Portugal3 sites

  • Uls Coimbra - Hosp. Univ. Coimbra

    Coimbra, 3000 075

    Active, not recruiting

  • Espaco Medico de Coimbra

    Coimbra, 3030 163

    Active, not recruiting

  • Uls Sao Joao

    Porto, 4200 319

    Active, not recruiting

Other trials in Portugal

Turkey (Türkiye)3 sites, 3 recruiting

  • Hacettepe University Medical Faculty

    Ankara, 06230

    Recruiting

  • Baskent University Ankara Hospital

    Ankara, 06490

    Recruiting

  • Dokuz Eylul University Medical Faculty

    Izmir, 35330

    Recruiting

Other trials in Turkey (Türkiye)

Czechia2 sites

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

    Active, not recruiting

  • AXON Clinical s.r.o.

    Prague, 15000

    Active, not recruiting

Other trials in Czechia

Netherlands2 sites

  • Radboudumc

    Nijmegen, 6525 GA

    Active, not recruiting

  • Het Oogziekenhuis Rotterdam

    Rotterdam, 3011

    Active, not recruiting

Other trials in Netherlands

Poland2 sites

  • Oftalmika

    Bydgoszcz, 85 631

    Active, not recruiting

  • Warszawski Szpital Okulistyczny

    Warsaw, 01 258

    Active, not recruiting

Other trials in Poland

Canada1 site

  • Alberta Retina Consultants

    Edmonton, Alberta, T5H 0X5

    Completed

Other trials in Canada

Denmark1 site

  • University Hospital Of Copenhagen, Glostrup Hospital

    Glostrup Municipality, 2600

    Active, not recruiting

Other trials in Denmark

Sweden1 site

  • S:t Eriks Ogonsjukhus

    Stockholm, 171 64

    Active, not recruiting

Other trials in Sweden

Switzerland1 site, 1 recruiting

  • Inselspital Universitatsspital Bern

    Bern, 3010

    Recruiting

Other trials in Switzerland

About this study

Official title: Long-term Extension Study for Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) in JNJ-81201887 Parent Clinical Studies

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.

Being tested
JNJ-81201887, Sham Procedure
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

    No study intervention will be administered as part of this LTE study.

  • Sham ProcedureOther

    No study intervention will be administered as part of this LTE study.

Study groups in NCT06635148
Study groupRoleWhat they receive
Arm A: JNJ-81201887 Low DoseExperimentalStudy participants who were enrolled and received treatment with low dose JNJ-81201887 in parent clinical studies (81201887MDG2001 [NCT05811351]; 81201887MDG1003) will enter this long-term extension (LTE) study. No study intervention will be administered as part of this study.
Receives: Drug: JNJ-81201887
Arm B: JNJ-81201887 High doseExperimentalStudy participants who were enrolled and received treatment with high dose JNJ-81201887 in parent clinical studies (81201887MDG2001 [NCT05811351]; 81201887MDG1003) will enter this LTE study. No study intervention will be administered as part of this study.
Receives: Drug: JNJ-81201887
Arm C: Sham ProcedureSham comparatorParticipants randomized to the sham arm in parent study 81201887MDG2001 (NCT05811351) will enter this LTE study. No intervention will be administered as part of this study.
Receives: Other: Sham Procedure

What is being measured

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

  1. Number of Participants with Ocular and Systemic Treatment-emergent Adverse Events (TEAEs)

    Number of participants with ocular and systemic TEAEs will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as any adverse event occurring at or after the administration of study intervention.

    Measured: Upto 5 Years

  2. Number of Participants with Abnormal Findings in Clinical Laboratory Assessments

    Number of participants with abnormal findings in clinical laboratory Assessments (including hematology and clinical chemistry) will be reported.

    Measured: Upto 5 Years

  3. Number of Participants with Abnormal Findings in Retinal imaging and Eye Examinations

    Number of participants with abnormal findings in retinal imaging (Fundus Autofluorescence, Spectral Domain Optical Coherence Tomography) and eye examinations will be reported.

    Measured: Upto 5 Years

  4. Change from Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score

    BCVA will be assessed using the ETDRS chart at a starting distance of 4 meters. The ETDRS score ranges from 0 to 100 letters, where an increase in the number of letters read correctly means that visual acuity has improved and vice-versa.

    Measured: Baseline up to 42 months

Timeline

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

  1. First posted10 Oct 2024
  2. Study start19 Sep 2024
  3. Primary completion24 Aug 2029 (estimated)
  4. Study completion16 Jul 2030 (estimated)

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Long-term safety study of a single intravitreal dose of JNJ-81201887 administered during parent studies (81201887MDG2001: Randomized trial; 81201887MDG1003: Non-randomized trial)
Masking
None (open label)
Enrolment
274 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06635148
Sponsor's protocol ID
81201887MDG3002
Other IDs
2022-500747-21-00
Status last verified
Nov 2026
First submitted
23 Sep 2024
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at 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 2/3 study testing JNJ-81201887 in people with Geographic Atrophy and Macular Degeneration, run by Janssen Research & Development, LLC at 104 sites in 18 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United States, Spain, Germany, Italy, Australia and 13 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Ocular and Systemic Treatment-emergent Adverse Events (TEAEs) (time frame: Upto 5 Years). The study lists 4 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 NCT06635148.

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 3 Nov 2026.

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