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| ID | Type | Description | Link |
|---|---|---|---|
| 81201887MDG2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2022-500746-16-00 | Registry Identifier | EUCT number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: JNJ-81201887 Low Dose | Experimental | Participants 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. |
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| Arm B: JNJ-81201887 High dose | Experimental | Participants 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. |
|
| Arm C: Sham Procedure | Sham Comparator | Participants 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-81201887 | Drug | JNJ-81201887 will be administered as intravitreal injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and Month 18 |
| 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. | Baseline to Month 18 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change From Baseline in Reading Speed at Month 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Research Institute | Phoenix | Arizona | 85053 | United States | ||
| Retina Associates Southwest PC |
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
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| Prednisone | Drug | Prednisone will be administered as oral capsule. |
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| Placebo | Other | Prednisone matching placebo will be administered as oral capsule. |
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| Triamcinolone | Drug | Triamcinolone (corticosteroid injection) periocular injection will be administered as per local practice. |
|
| Sham Procedure | Other | Sham injections matching to single JNJ-81201887 injection and matching to corticosteroid (triamcinolone) periocular injection will be administered. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Tucson |
| Arizona |
| 85704 |
| United States |
| Retina Consultants of Orange County | Fullerton | California | 92835 | United States |
| Retina Associates Of Southern California | Huntington Beach | California | 92647 | United States |
| Shiley Eye Institute Jacobs Retina Center | La Jolla | California | 92093 0946 | United States |
| Jules Stein Eye Institute UCLA | Los Angeles | California | 90095 | United States |
| The Retina Partners | Los Angeles | California | 91436 | United States |
| California Retina Consultants | Oxnard | California | 93036 | United States |
| Stanford Health Care | Palo Alto | California | 94303 | United States |
| California Eye Medical Specialists | Pasadena | California | 91107 | United States |
| Retina Consultants San Diego | Poway | California | 92064 | United States |
| Retina Consultants of Southern California | Redlands | California | 92374 | United States |
| Bay Area Retina Associates | Walnut Creek | California | 94598 | United States |
| Colorado Retina - Lakewood Clinic | Lakewood | Colorado | 80228 | United States |
| Retina Group of Florida | Fort Lauderdale | Florida | 33308 | United States |
| National Opthalmic Research Institute | Fort Myers | Florida | 33912 | United States |
| VitreoRetinal Associates, PA | Gainesville | Florida | 32607 | United States |
| MedEye Associates | Miami | Florida | 33143 | United States |
| Retina Specialty Institute | Pensacola | Florida | 32503 | United States |
| Fort Lauderdale Eye Institute | Plantation | Florida | 33324 | United States |
| Retina Vitreous Associates of Florida | St. Petersburg | Florida | 33711 | United States |
| East Florida Eye Institute | Stuart | Florida | 34994 | United States |
| Georgia Retina | Marietta | Georgia | 30060 | United States |
| Marietta Eye Clinic | Marietta | Georgia | 30060 | United States |
| University Of Illinois | Chicago | Illinois | 60612 | United States |
| Retina Associates | Elmhurst | Illinois | 60126 | United States |
| University Retina | Lemont | Illinois | 60439 | United States |
| Midwest Eye Institute | Carmel | Indiana | 46032 | United States |
| Maine Eye Center | Portland | Maine | 04101 | United States |
| Retina Specialists | Baltimore | Maryland | 21204 | United States |
| The Retina Care Center | Baltimore | Maryland | 21209 | United States |
| The Retina Group of Washington | Chevy Chase | Maryland | 20815 | United States |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Vitreo Retinal Associates-Worcester | Worcester | Massachusetts | 01605 | United States |
| Foundation for Vision Research | Grand Rapids | Michigan | 49546 | United States |
| Associated Retinal Consultants P.C. | Royal Oak | Michigan | 48073 | United States |
| Retina Consultants of Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| The Retina Institute | St Louis | Missouri | 63144 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
| Wills Eye/Mid Atlantic Retina | Cherry Hill | New Jersey | 08034 | United States |
| Long Island Vitreo Retinal Consultants | Great Neck | New York | 11021 | United States |
| Retina-Vitreous Surgeons of Central New York | Liverpool | New York | 13088 | United States |
| Vitreous Retina Macula Consultants of New York | New York | New York | 10022 | United States |
| Retina Consultants PLLC | Slingerlands | New York | 12159 | United States |
| Opthalmic Consultants of the Capital Region | Troy | New York | 12180 | United States |
| Asheville Eye Associates - Western Carolina Retinal Associates | Asheville | North Carolina | 28803 | United States |
| Duke University | Durham | North Carolina | 27705-4699 | United States |
| Graystone Eye | Hickory | North Carolina | 28602 | United States |
| NC Retina Associates | Wake Forest | North Carolina | 27587 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Verum Research LLC | Eugene | Oregon | 97401 | United States |
| Casey Eye Institute | Portland | Oregon | 97239 | United States |
| Cascade Medical Research Institute, LLC | Springfield | Oregon | 97477 | United States |
| Erie Retina Research | Erie | Pennsylvania | 16505 | United States |
| Charleston Neuroscience Institute, LLC | Beaufort | South Carolina | 29902 | United States |
| Charles Retina Institute | Germantown | Tennessee | 38138 | United States |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | United States |
| Panhandle Eye Group LLP-Southwest Retina Specialists | Amarillo | Texas | 79106 | United States |
| Austin Clinical Research | Austin | Texas | 78750 | United States |
| Retina and Vitreous of Texas, PLLC | Bellaire | Texas | 77401 | United States |
| Retina Consultants of Texas 2 | Bellaire | Texas | 77401 | United States |
| Retina Foundation of the Southwest | Dallas | Texas | 75231 | United States |
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
| UT Southwestern | Dallas | Texas | 75390 | United States |
| Texas Retina Associates 1 | Fort Worth | Texas | 76104 | United States |
| Houston Eye Associates | Houston | Texas | 77025 | United States |
| San Antonio Eye Center | San Antonio | Texas | 78215 | United States |
| Retina Associates Of South Texas P A | San Antonio | Texas | 78240 | United States |
| Retina Consultants of Texas | San Antonio | Texas | 78240 | United States |
| Retina Consultants of Texas | The Woodlands | Texas | 77384 | United States |
| Strategic Clinical Research Group | Willow Park | Texas | 76087 | United States |
| Retina Associates of Utah P C | Salt Lake City | Utah | 84107 | United States |
| Rocky Mountain Retina Consultants | Salt Lake City | Utah | 84107 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | United States |
| Wagner Kapoor Research institute | Norfolk | Virginia | 23502 | United States |
| Spokane Eye Clinical Research | Spokane | Washington | 99204 | United States |
| Adelaide Eye and Retina Centre | Adelaide | 5000 | Australia |
| Centre for Eye Research Australia | East Melbourne | 3002 | Australia |
| Strathfield Retina Clinic | Strathfield | 2135 | Australia |
| Sydney Retina Clinic and Day Surgery | Sydney | 2000 | Australia |
| Sydney West Retina | Westmead | 2145 | Australia |
| Ziekenhuis Oost-Limburg | Genk | 3600 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman | Liège | 4000 | Belgium |
| Calgary Retina Consultants | Calgary | Alberta | T2H 0C8 | Canada |
| Alberta Retina Consultants | Edmonton | Alberta | T5H 0X5 | Canada |
| The Ottawa Hospital Research Institute | Ottawa | Ontario | K1H 8L6 | Canada |
| The Retina Centre of Ottawa | Ottawa | Ontario | K2B 7E9 | Canada |
| Institut De L'oeil Des Laurentides | Boisbriand | Quebec | J7H 0E8 | Canada |
| OFTEX Ltd. - EYE CENTER | Pardubice | 530 02 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | 100 34 | Czechia |
| AXON Clinical s.r.o. | Prague | 15000 | Czechia |
| Aalborg University Hospital | Aalborg | 9000 | Denmark |
| University Hospital Of Copenhagen, Glostrup Hospital | Glostrup Municipality | 2600 | Denmark |
| Zealand University Hospital | Roskilde | 4000 | Denmark |
| Charite Universitaetsmedizin Berlin | Berlin | 12203 | Germany |
| Universitaets-Augenklinik Bonn | Bonn | 53127 | Germany |
| Universitatsklinikum Gießen - Klinik und Poliklinik fur Augenheilkunde | Giessen | 35392 | Germany |
| Klinikum Gottingen der Georg August Universitat | Göttingen | 37075 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitatsklinikum Schleswig Holstein Kiel | Kiel | 24105 | Germany |
| Universitaetsklinikum Leipzig | Leipzig | 04103 | Germany |
| Klinikum Ludwigshafen | Ludwigshafen am Rhein | 67063 | Germany |
| Augenzentrum am St Franziskus Hospital Munster | Münster | 48145 | Germany |
| Universitaetsklinikum Muenster | Münster | 48149 | Germany |
| Universitaetsklinikum Tuebingen | Tübingen | 72076 | Germany |
| Eszak Pesti Centrumkorhaz Honvedkorhaz | Budapest | 1062 | Hungary |
| Ganglion Orvosi Központ | Pécs | 7621 | Hungary |
| Zala Megyei Szent Rafael Korhaz | Zalaegerszeg | 8900 | Hungary |
| Arcispedale S. Anna Ferrara | Ferrara | 44124 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano | Milan | 20122 | Italy |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Sacco Hospital | Milan | 20157 | Italy |
| Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli | Naples | 80138 | Italy |
| Policlinico Universitario Agostino Gemelli | Roma | 00168 | Italy |
| Amsterdam University Medical Centers Location Academic Medical Center | Amsterdam | 1105 AZ | Netherlands |
| Radboudumc | Nijmegen | 6525 GA | Netherlands |
| Het Oogziekenhuis Rotterdam | Rotterdam | 3011 | Netherlands |
| Oculomedica | Bydgoszcz | 85 157 | Poland |
| Oftalmika | Bydgoszcz | 85 631 | Poland |
| Uno Med | Tarnów | 33 100 | Poland |
| Warszawski Szpital Okulistyczny | Warsaw | 01 258 | Poland |
| Uls Coimbra - Hosp. Univ. Coimbra | Coimbra | 3000 075 | Portugal |
| Espaco Medico de Coimbra | Coimbra | 3030-163 | Portugal |
| Uls Sao Joao - Hosp. Sao Joao | Porto | 4200 319 | Portugal |
| Centro de Oftalmologia Barraquer | Barcelona | 08021 | Spain |
| Centro Medico Teknon S.L. | Barcelona | 08022 | Spain |
| Inst. Cat. de Retina | Barcelona | 08022 | Spain |
| Hosp. Dos de Maig | Barcelona | 08025 | Spain |
| Inst. de Microcirugia Ocular | Barcelona | 08035 | Spain |
| Clinica Oftalvist Valencia | Burjassot | 46100 | Spain |
| Hosp. La Arruzafa | Córdoba | 14012 | Spain |
| Hosp. Univ. Donostia | Donostia / San Sebastian | 20014 | Spain |
| Hosp Univ Fund Jimenez Diaz | Madrid | 28040 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Clinica Baviera Madrid Castellana | Madrid | 28046 | Spain |
| Hosp. Univ. Pta. de Hierro Majadahonda | Majadahonda | 28222 | Spain |
| Clinica Univ. de Navarra | Pamplona | 31008 | Spain |
| Idc Salud Hosp. Gral. de Catalunya | Sant Cugat del Vallès | 08195 | Spain |
| Hosp. Prov. Do Conxo | Santiago de Compostela | 15706 | Spain |
| Hosp. Virgen Del Rocio | Seville | 41013 | Spain |
| Hosp. Clinico Univ. Lozano Blesa | Zaragoza | 50009 | Spain |
| Hosp. Univ. Miguel Servet | Zaragoza | 50009 | Spain |
| S:t Eriks Ogonsjukhus | Stockholm | 171 64 | Sweden |
| Inselspital Universitatsspital Bern | Bern | 3010 | Switzerland |
| Hacettepe University Hospital | Ankara | 06230 | Turkey (Türkiye) |
| Baskent University Ankara Hospital | Ankara | 06490 | Turkey (Türkiye) |
| Ankara Bilkent Sehir Hastanesi | Ankara | 06800 | Turkey (Türkiye) |
| Dokuz Eylul University Hospital | Izmir | 35330 | Turkey (Türkiye) |
| Konya Selcuk University Medical Faculty | Konya | 42250 | Turkey (Türkiye) |
| Bristol Eye Hospital | Bristol | BS1 2LX | United Kingdom |
| Moorfields Eye Hospital | London | EC1V 2PD | United Kingdom |
| Central Middlesex Hospital | London | NW10 7NS | United Kingdom |
| The Retina Clinic London | London | W1G 9AX | United Kingdom |
| Manchester Royal Eye Hospital | Manchester | M13 9WL | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Oxford Eye Hospital | Oxford | OX3 9DU | United Kingdom |
| Southampton University Hospital | Southampton | SO16 6YD | 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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| ID | Term |
|---|---|
| D011241 | Prednisone |
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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