Long-term Extension Study for Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) in JNJ-81201887 Parent Clinical Studies
| Registry | NCT06635148 |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 274 (Estimated) |
| Sponsor | Janssen Research & Development, LLC (Industry) |
| Conditions | Geographic Atrophy, Macular Degeneration |
| Interventions | JNJ-81201887, Sham Procedure (Drug, other) |
| Dates | start 2024-09-19, primary completion 2029-08-24 (estimated), completion 2030-07-16 (estimated), first posted 2024-10-10, last updated 2026-09-30 |
| Locations | 104 sites in United States, Australia, Belgium, Canada, China, Czechia, Denmark, Germany and 10 more countries |
Related Papers Related Patents Related Grants Related Experts
All trials for Geographic Atrophy All trials for Macular Degeneration All trials of JNJ-81201887 All trials of Sham Procedure
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm A: JNJ-81201887 Low Dose | Experimental | Drug: JNJ-81201887 | Study 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. |
| Arm B: JNJ-81201887 High dose | Experimental | Drug: JNJ-81201887 | Study 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. |
| Arm C: Sham Procedure | Sham comparator | Other: Sham Procedure | Participants 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. |
Sex: All, ages: 60 Years to any
Inclusion Criteria: * 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 Exclusion Criteria: * There are no exclusion criteria for this LTE study
| Facility | City | Country | Status |
|---|---|---|---|
| Retina Associates Southwest PC | Tucson, Arizona | United States | Recruiting |
| Retina Consultants of Orange County | Fullerton, California | United States | Recruiting |
| Shiley Eye Institute Jacobs Retina Center | La Jolla, California | United States | Recruiting |
| California Retina Consultants | Oxnard, California | United States | Recruiting |
| California Eye Medical Specialists | Pasadena, California | United States | Recruiting |
| Retina Consultants San Diego | Poway, California | United States | Recruiting |
| Bay Area Retina Associates | Walnut Creek, California | United States | Recruiting |
| Retina Group of Florida | Fort Lauderdale, Florida | United States | Recruiting |
| VitreoRetinal Associates, PA | Gainesville, Florida | United States | Recruiting |
| Retina Specialty Institute | Pensacola, Florida | United States | Recruiting |
| Retina Vitreous Associates of Florida | St. Petersburg, Florida | United States | Recruiting |
| Georgia Retina | Marietta, Georgia | United States | Recruiting |
| Marietta Eye Clinic | Marietta, Georgia | United States | Recruiting |
| University Retina | Lemont, Illinois | United States | Recruiting |
| Midwest Eye Institute | Carmel, Indiana | United States | Recruiting |
| Maine Eye Center | Portland, Maine | United States | Recruiting |
| Retina Specialists | Baltimore, Maryland | United States | Recruiting |
| The Retina Group of Washington | Chevy Chase, Maryland | United States | Recruiting |
| Cumberland Valley Retina Consultants | Hagerstown, Maryland | United States | Recruiting |
| Ophthalmic Consultants of Boston | Boston, Massachusetts | United States | Recruiting |
| Foundation for Vision Research | Grand Rapids, Michigan | United States | Recruiting |
| Retina Consultants of Minnesota | Saint Louis Park, Minnesota | United States | Recruiting |
| The Retina Institute | St Louis, Missouri | United States | Recruiting |
| Sierra Eye Associates | Reno, Nevada | United States | Recruiting |
| Retina-Vitreous Surgeons of Central New York | Liverpool, New York | United States | Recruiting |
| Asheville Eye Associates - Western Carolina Retinal Associates | Asheville, North Carolina | United States | Recruiting |
| Duke Eye Center | Durham, North Carolina | United States | Recruiting |
| Graystone Eye | Hickory, North Carolina | United States | Recruiting |
| NC Retina Associates | Wake Forest, North Carolina | United States | Recruiting |
| Cincinnati Eye Institute | Cincinnati, Ohio | United States | Recruiting |
| Cleveland Clinic Main Campus | Cleveland, Ohio | United States | Recruiting |
| Verum Research LLC | Eugene, Oregon | United States | Recruiting |
| Cascade Medical Research Institute, LLC | Springfield, Oregon | United States | Recruiting |
| Erie Retina Research | Erie, Pennsylvania | United States | Recruiting |
| Charleston Neuroscience Institute, LLC | Beaufort, South Carolina | United States | Recruiting |
| Austin Clinical Research | Austin, Texas | United States | Recruiting |
| Texas Retina Associates | Dallas, Texas | United States | Recruiting |
| UT Southwestern Medical Center | Dallas, Texas | United States | Recruiting |
| Retina Associates Of South Texas P A | San Antonio, Texas | United States | Recruiting |
| Retina Consultants of Texas | The Woodlands, Texas | United States | Recruiting |
| Strategic Clinical Research Group | Willow Park, Texas | United States | Recruiting |
| University of Utah | Salt Lake City, Utah | United States | Recruiting |
| Piedmont Eye Center | Lynchburg, Virginia | United States | Recruiting |
| Wagner Kapoor Research institute | Norfolk, Virginia | United States | Recruiting |
| Spokane Eye Clinical Research | Spokane, Washington | United States | Recruiting |
| Centre for Eye Research Australia | East Melbourne | Australia | Recruiting |
| Strathfield Retina Clinic | Strathfield | Australia | Recruiting |
| Sydney Retina Clinic and Day Surgery | Sydney | Australia | Recruiting |
| Sydney West Retina | Westmead | Australia | Recruiting |
| Ziekenhuis Oost-Limburg | Genk | Belgium | Active not recruiting |
| UZ Gent | Ghent | Belgium | Active not recruiting |
| UZ Leuven Gasthuisberg | Leuven | Belgium | Active not recruiting |
| Alberta Retina Consultants | Edmonton, Alberta | Canada | Completed |
| Beijing Tongren Hospital CMU | Beijing | China | Recruiting |
| West China Hospital Si Chuan University | Chengdu | China | Recruiting |
| Shanghai General Hospital | Shanghai | China | Recruiting |
| Fakultni nemocnice Kralovske Vinohrady | Prague | Czechia | Recruiting |
| AXON Clinical s.r.o. | Prague | Czechia | Recruiting |
| University Hospital Of Copenhagen, Glostrup Hospital | Glostrup Municipality | Denmark | Active not recruiting |
| Universitaets-Augenklinik Bonn | Bonn | Germany | Recruiting |
| Klinikum Gottingen der Georg August Universitat | Göttingen | Germany | Recruiting |
| Medizinische Hochschule Hannover | Hanover | Germany | Recruiting |
| Universitaetsklinikum Leipzig | Leipzig | Germany | Recruiting |
| Klinikum Ludwigshafen | Ludwigshafen am Rhein | Germany | Recruiting |
| Augenzentrum am St Franziskus Hospital Munster | Münster | Germany | Recruiting |
| Universitaetsklinikum Tuebingen | Tübingen | Germany | Recruiting |
| Eszak Pesti Centrumkorhaz Honvedkorhaz | Budapest | Hungary | Recruiting |
| Ganglion Orvosi Központ | Pécs | Hungary | Recruiting |
| Zala Varmegyei Szent Rafael Korhaz | Zalaegerszeg | Hungary | Recruiting |
| Azienda Ospedaliero Universitaria di Ferrara | Ferrara | Italy | Recruiting |
| ASST Fatebenefratelli Sacco | Milan | Italy | Recruiting |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milan | Italy | Recruiting |
| IRCCS Ospedale San Raffaele | Milan | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Luigi Vanvitelli | Naples | Italy | Recruiting |
| Fondazione Policlinico Universitario A Gemelli IRCCS | Roma | Italy | Recruiting |
| Radboudumc | Nijmegen | Netherlands | Active not recruiting |
| Het Oogziekenhuis Rotterdam | Rotterdam | Netherlands | Active not recruiting |
| Oftalmika | Bydgoszcz | Poland | Active not recruiting |
| Warszawski Szpital Okulistyczny | Warsaw | Poland | Active not recruiting |
| Uls Coimbra - Hosp. Univ. Coimbra | Coimbra | Portugal | Active not recruiting |
| Espaco Medico de Coimbra | Coimbra | Portugal | Active not recruiting |
| Uls Sao Joao | Porto | Portugal | Active not recruiting |
| Centro de Oftalmologia Barraquer | Barcelona | Spain | Recruiting |
| Centro Medico Teknon S.L. | Barcelona | Spain | Recruiting |
| Inst. Cat. de Retina | Barcelona | Spain | Recruiting |
| Clinica Oftalvist Valencia | Burjassot | Spain | Recruiting |
| Hosp. La Arruzafa | Córdoba | Spain | Recruiting |
| Hosp Univ Fund Jimenez Diaz | Madrid | Spain | Recruiting |
| Hosp. Univ. 12 de Octubre | Madrid | Spain | Recruiting |
| Clinica Baviera Madrid Castellana | Madrid | Spain | Recruiting |
| Hosp. Univ. Pta. de Hierro Majadahonda | Majadahonda | Spain | Recruiting |
| Clinica Univ. de Navarra | Pamplona | Spain | Recruiting |
| Idc Salud Hosp. Gral. de Catalunya | Sant Cugat del Vallès | Spain | Recruiting |
| Hosp. Virgen Del Rocio | Seville | Spain | Recruiting |
| Hosp. Clinico Univ. Lozano Blesa | Zaragoza | Spain | Recruiting |
| S:t Eriks Ogonsjukhus | Stockholm | Sweden | Active not recruiting |
| Inselspital Universitatsspital Bern | Bern | Switzerland | Recruiting |
| Hacettepe University Medical Faculty | Ankara | Turkey (Türkiye) | Recruiting |
| Baskent University Ankara Hospital | Ankara | Turkey (Türkiye) | Recruiting |
| Dokuz Eylul University Medical Faculty | Izmir | Turkey (Türkiye) | Recruiting |
4 more sites not listed.