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| ID | Type | Description | Link |
|---|---|---|---|
| 81201887MDG3002 | Other Identifier | Janssen Research & Development, LLC | |
| 2022-500747-21-00 | Registry Identifier | EUCT number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: JNJ-81201887 Low Dose | Experimental | 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. |
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| Arm B: JNJ-81201887 High dose | Experimental | 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. |
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| Arm C: Sham Procedure | Sham Comparator | Participants randomized to the sham arm in parent study 81201887MDG2001 (NCT05811351) may have the option to receive JNJ-81201887 open-label treatment under a separate protocol after unmasking of that study; and will enter this LTE study. No intervention will be administered as part of this study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-81201887 | Drug | No study intervention will be administered as part of this LTE study. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Upto 5 Years |
| 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. | Upto 5 Years |
| 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, Color Fundus Photography) and eye examinations will be reported. | Upto 5 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Associates Southwest PC | Recruiting | Tucson | Arizona | 85704 | United States | |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/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
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Long-term safety study of a single intravitreal dose of JNJ-81201887 administered during parent studies (81201887MDG2001: Randomized trial; 81201887MDG1003: Non-randomized trial)
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| Sham Procedure | Other | No study intervention will be administered as part of this LTE study. |
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| Retina Consultants of Orange County |
| Recruiting |
| Fullerton |
| California |
| 92835 |
| United States |
| Shiley Eye Institute Jacobs Retina Center | Recruiting | La Jolla | California | 92093 0946 | United States |
| California Retina Consultants | Recruiting | Oxnard | California | 93036 | United States |
| California Eye Medical Specialists | Recruiting | Pasadena | California | 91107 | United States |
| Retina Consultants San Diego | Recruiting | Poway | California | 92064 | United States |
| Bay Area Retina Associates | Recruiting | Walnut Creek | California | 94598 | United States |
| Retina Group of Florida | Recruiting | Fort Lauderdale | Florida | 33308 | United States |
| VitreoRetinal Associates, PA | Recruiting | Gainesville | Florida | 32607 | United States |
| Retina Specialty Institute | Recruiting | Pensacola | Florida | 32503 | United States |
| Retina Vitreous Associates of Florida | Recruiting | St. Petersburg | Florida | 33711 | United States |
| Georgia Retina | Recruiting | Marietta | Georgia | 30060 | United States |
| Marietta Eye Clinic | Recruiting | Marietta | Georgia | 30060 | United States |
| University Retina | Recruiting | Lemont | Illinois | 60439 | United States |
| Midwest Eye Institute | Recruiting | Carmel | Indiana | 46032 | United States |
| Maine Eye Center | Recruiting | Portland | Maine | 04101 | United States |
| Retina Specialists | Recruiting | Baltimore | Maryland | 21204 | United States |
| The Retina Group of Washington | Recruiting | Chevy Chase | Maryland | 20815 | United States |
| Cumberland Valley Retina Consultants | Recruiting | Hagerstown | Maryland | 21740 | United States |
| Ophthalmic Consultants of Boston | Recruiting | Boston | Massachusetts | 02114 | United States |
| Foundation for Vision Research | Recruiting | Grand Rapids | Michigan | 49546 | United States |
| Retina Consultants of Minnesota | Recruiting | Saint Louis Park | Minnesota | 55416 | United States |
| The Retina Institute | Recruiting | St Louis | Missouri | 63128 | United States |
| Sierra Eye Associates | Recruiting | Reno | Nevada | 89502 | United States |
| Retina-Vitreous Surgeons of Central New York | Recruiting | Liverpool | New York | 13088 | United States |
| Asheville Eye Associates - Western Carolina Retinal Associates | Recruiting | Asheville | North Carolina | 28803 | United States |
| Duke Eye Center | Recruiting | Durham | North Carolina | 27705 | United States |
| Graystone Eye | Recruiting | Hickory | North Carolina | 28602 | United States |
| NC Retina Associates | Recruiting | Wake Forest | North Carolina | 27587 | United States |
| Cincinnati Eye Institute | Recruiting | Cincinnati | Ohio | 45242 | United States |
| Cleveland Clinic Main Campus | Recruiting | Cleveland | Ohio | 44195 | United States |
| Verum Research LLC | Recruiting | Eugene | Oregon | 97401 | United States |
| Cascade Medical Research Institute, LLC | Recruiting | Springfield | Oregon | 97477 | United States |
| Erie Retina Research | Recruiting | Erie | Pennsylvania | 16505 | United States |
| Charleston Neuroscience Institute, LLC | Recruiting | Beaufort | South Carolina | 29902 | United States |
| Austin Clinical Research | Recruiting | Austin | Texas | 78750 | United States |
| Texas Retina Associates | Recruiting | Dallas | Texas | 75231 | United States |
| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
| Retina Associates Of South Texas P A | Recruiting | San Antonio | Texas | 78240 | United States |
| Retina Consultants of Texas | Recruiting | The Woodlands | Texas | 77384 | United States |
| Strategic Clinical Research Group | Recruiting | Willow Park | Texas | 76087 | United States |
| University of Utah | Recruiting | Salt Lake City | Utah | 84132 | United States |
| Piedmont Eye Center | Recruiting | Lynchburg | Virginia | 24502 | United States |
| Wagner Kapoor Research institute | Recruiting | Norfolk | Virginia | 23502 | United States |
| Spokane Eye Clinical Research | Recruiting | Spokane | Washington | 99204 | United States |
| Centre for Eye Research Australia | Recruiting | East Melbourne | 3002 | Australia |
| Strathfield Retina Clinic | Recruiting | Strathfield | 2135 | Australia |
| Sydney Retina Clinic and Day Surgery | Recruiting | Sydney | 2000 | Australia |
| Sydney West Retina | Recruiting | Westmead | 2145 | Australia |
| Ziekenhuis Oost-Limburg | Active, not recruiting | Genk | 3600 | Belgium |
| UZ Gent | Active, not recruiting | Ghent | 9000 | Belgium |
| UZ Leuven Gasthuisberg | Active, not recruiting | Leuven | 3000 | Belgium |
| Alberta Retina Consultants | Recruiting | Edmonton | Alberta | T5H 0X5 | Canada |
| Beijing Tongren Hospital CMU | Recruiting | Beijing | 100730 | China |
| West China Hospital Si Chuan University | Recruiting | Chengdu | 610041 | China |
| Shanghai General Hospital | Recruiting | Shanghai | 200080 | China |
| Fakultni nemocnice Kralovske Vinohrady | Recruiting | Prague | 100 34 | Czechia |
| AXON Clinical s.r.o. | Recruiting | Prague | 15000 | Czechia |
| University Hospital Of Copenhagen, Glostrup Hospital | Active, not recruiting | Glostrup Municipality | 2600 | Denmark |
| Universitaets-Augenklinik Bonn | Recruiting | Bonn | 53127 | Germany |
| Klinikum Gottingen der Georg August Universitat | Recruiting | Göttingen | 37075 | Germany |
| Medizinische Hochschule Hannover | Recruiting | Hanover | 30625 | Germany |
| Universitaetsklinikum Leipzig | Recruiting | Leipzig | 04103 | Germany |
| Klinikum Ludwigshafen | Recruiting | Ludwigshafen am Rhein | 67063 | Germany |
| Augenzentrum am St Franziskus Hospital Munster | Recruiting | Münster | 48145 | Germany |
| Universitaetsklinikum Tuebingen | Recruiting | Tübingen | 72076 | Germany |
| Eszak Pesti Centrumkorhaz Honvedkorhaz | Recruiting | Budapest | 1062 | Hungary |
| Ganglion Orvosi Központ | Recruiting | Pécs | 7621 | Hungary |
| Zala Varmegyei Szent Rafael Korhaz | Recruiting | Zalaegerszeg | 8900 | Hungary |
| Azienda Ospedaliero Universitaria di Ferrara | Recruiting | Ferrara | 44124 | Italy |
| ASST Fatebenefratelli Sacco | Recruiting | Milan | 20157 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Recruiting | Milan | 20122 | Italy |
| IRCCS Ospedale San Raffaele | Recruiting | Milan | 20132 | Italy |
| Azienda Ospedaliero Universitaria Luigi Vanvitelli | Recruiting | Naples | 80138 | Italy |
| Fondazione Policlinico Universitario A Gemelli IRCCS | Recruiting | Roma | 00168 | Italy |
| Radboudumc | Active, not recruiting | Nijmegen | 6525 GA | Netherlands |
| Het Oogziekenhuis Rotterdam | Active, not recruiting | Rotterdam | 3011 | Netherlands |
| Oftalmika | Active, not recruiting | Bydgoszcz | 85 631 | Poland |
| Warszawski Szpital Okulistyczny | Active, not recruiting | Warsaw | 01 258 | Poland |
| Uls Coimbra - Hosp. Univ. Coimbra | Active, not recruiting | Coimbra | 3000 075 | Portugal |
| Espaco Medico de Coimbra | Active, not recruiting | Coimbra | 3030 163 | Portugal |
| Uls Sao Joao | Recruiting | Porto | 4200 319 | Portugal |
| Centro de Oftalmologia Barraquer | Recruiting | Barcelona | 08021 | Spain |
| Centro Medico Teknon S.L. | Recruiting | Barcelona | 08022 | Spain |
| Inst. Cat. de Retina | Recruiting | Barcelona | 08022 | Spain |
| Clinica Oftalvist Valencia | Recruiting | Burjassot | 46100 | Spain |
| Hosp. La Arruzafa | Recruiting | Córdoba | 14012 | Spain |
| Hosp Univ Fund Jimenez Diaz | Recruiting | Madrid | 28040 | Spain |
| Hosp. Univ. 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Clinica Baviera Madrid Castellana | Recruiting | Madrid | 28046 | Spain |
| Hosp. Univ. Pta. de Hierro Majadahonda | Recruiting | Majadahonda | 28222 | Spain |
| Clinica Univ. de Navarra | Recruiting | Pamplona | 31008 | Spain |
| Idc Salud Hosp. Gral. de Catalunya | Recruiting | Sant Cugat del Vallès | 08195 | Spain |
| Hosp. Virgen Del Rocio | Recruiting | Seville | 41013 | Spain |
| Hosp. Clinico Univ. Lozano Blesa | Recruiting | Zaragoza | 50009 | Spain |
| S:t Eriks Ogonsjukhus | Active, not recruiting | Stockholm | 171 64 | Sweden |
| Inselspital Universitatsspital Bern | Recruiting | Bern | 3010 | Switzerland |
| Hacettepe University Medical Faculty | Recruiting | Ankara | 06230 | Turkey (Türkiye) |
| Baskent University Ankara Hospital | Recruiting | Ankara | 06490 | Turkey (Türkiye) |
| Dokuz Eylul University Medical Faculty | Recruiting | Izmir | 35330 | Turkey (Türkiye) |
| Bristol Eye Hospital | Active, not recruiting | Bristol | BS1 2LX | United Kingdom |
| Oxford Eye Hospital | Active, not recruiting | Headington | OX3 9DU | United Kingdom |
| The Retina Clinic London | Active, not recruiting | London | W1G 9AX | United Kingdom |
| Royal Victoria Infirmary | Active, not recruiting | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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