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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000046-15 | EudraCT Number |
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This is a multicenter prospective study in participants with intermediate age-related macular degeneration (iAMD). One primary objective of this study is to assess iAMD disease progression, by the timeline and rates of conversion for high-risk iAMD at baseline to more advanced atrophic AMD stages. The other primary objective of this observational study is to assess the feasibility of measuring the rate of photoreceptor loss as a potential clinical endpoint. The study will consist of an observation period of approximately 3 years (~144 weeks) for participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermediate AMD | Participants with iAMD will be evaluated for the progression of iAMD to more advanced atrophic AMD stages, such as nascent geographic atrophy (nGA) or incomplete retinal pigment epithelium and outer retinal atrophy (iRORA), and subsequently from nGA or iRORA to complete retinal pigment epithelium (cRORA) and outer retinal atrophy or geographic atrophy (GA), on Day 1 and thereafter every 12 weeks up to the end of the Observation Period, approximately 3 years. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention will be administered in this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Conversion from iAMD to nGA /iRORA | Baseline up to 3 years | |
| Rate of Conversion from nGA/iRORA to cRORA/GA | Baseline up to 3 years | |
| Rate of Photoreceptor Loss as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) | Baseline up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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The study will enroll participants with high risk intermediate AMD.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Partners of Northwest Arkansas, PLLC | Springdale | Arkansas | 72764 | United States | ||
| The Retina Partners |
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| Encino |
| California |
| 91436-2018 |
| United States |
| Retina Consultants of Orange County | Fullerton | California | 92835 | United States |
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | United States |
| Retina Consultants, San Diego | Poway | California | 92064 | United States |
| UC Davis Eye Center | Sacramento | California | 95817 | United States |
| Retinal Consultants Medical Group | Sacramento | California | 95841-2013 | United States |
| Bay Area Retina Associates | Walnut Creek | California | 94598 | United States |
| Southwest Retina Consultants | Durango | Colorado | 81303 | United States |
| Eye Care Center of Northern Colorado PC | Longmont | Colorado | 80503 | United States |
| Advanced Research | Coral Springs | Florida | 33067 | United States |
| Rand Eye Institute | Deerfield Beach | Florida | 33064 | United States |
| National Ophthalmic Research Institute | Fort Myers | Florida | 33912 | United States |
| Florida Eye Associates | Melbourne | Florida | 32901 | United States |
| Southeast Retina Center | Augusta | Georgia | 30909 | United States |
| University Retina and Macula Associates, PC | Oak Forest | Illinois | 60452 | United States |
| Raj K. Maturi, MD PC | Indianapolis | Indiana | 46290 | United States |
| Wolfe Eye Clinic | West Des Moines | Iowa | 50266 | United States |
| Cumberland Valley Retina Consultants PC | Hagerstown | Maryland | 21740 | United States |
| New England Retina Consultants | Springfield | Massachusetts | 01107 | United States |
| Foundation for Vision Research | Grand Rapids | Michigan | 49546 | United States |
| Deep Blue Retina Clinical Research | Southaven | Mississippi | 38671 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
| Eye Associates of New Mexico | Albuquerque | New Mexico | 87109 | United States |
| Vitreous Retina Macula Consultants of New York | New York | New York | 10022 | United States |
| Ophthalmic Consultants of Long Island | Rockville Centre | New York | 11570 | United States |
| Duke Eye Center | Durham | North Carolina | 27705 | United States |
| Cleveland Clinic Cole Eye Institute | Cleveland | Ohio | 44195 | United States |
| Retina Vitreous Center | Edmond | Oklahoma | 73013 | United States |
| EyeHealth Northwest | Portland | Oregon | 97224 | United States |
| Casey Eye Institute - OHSU | Portland | Oregon | 97239 | United States |
| Erie Retinal Surgery | Erie | Pennsylvania | 16507 | United States |
| Scheie Eye Institute | Philadelphia | Pennsylvania | 19104 | United States |
| Palmetto Retina Center, LLC | West Columbia | South Carolina | 29169 | United States |
| Tennessee Retina PC | Nashville | Tennessee | 37203 | United States |
| W Texas Retina Consultants PA | Abilene | Texas | 79606 | United States |
| Austin Retina Associates | Austin | Texas | 78705 | United States |
| Austin Clinical Research LLC | Austin | Texas | 78750 | United States |
| Retina Consultants of Texas | Bellaire | Texas | 77401 | United States |
| Retina Foundation of the Southwest | Dallas | Texas | 75231 | United States |
| Retina Specialists | DeSoto | Texas | 75115 | United States |
| San Antonio Eye Center | San Antonio | Texas | 78215 | United States |
| Rocky Mountain Retina | Salt Lake City | Utah | 84107 | United States |
| Wagner Kapoor Institute | Norfolk | Virginia | 23502 | United States |
| Spokane Eye Clinical Research | Spokane | Washington | 99204 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53705-2275 | United States |
| Marsden Eye Specialists | Parramatta | New South Wales | 2150 | Australia |
| Sydney Retina Clinic and Day Surgery | Sydney | New South Wales | 2000 | Australia |
| Adelaide Eye and Retina Centre | Adelaide | South Australia | 5000 | Australia |
| Centre For Eye Research Australia | East Melbourne | Victoria | 3002 | Australia |
| The Lions Eye Institute | Nedlands | Western Australia | 6009 | Australia |
| Centre Hospitalier Intercommunal | Créteil | 94010 | France |
| Centre Ophtalmologique Pole Vision | Écully | 69130 | France |
| CHU de GRENOBLE | Grenoble | 38043 | France |
| Hôpital de La Croix Rousse | Lyon | 69004 | France |
| Centre Ophtalmologique Maison-Rouge | Strasbourg | 67000 | France |
| Universitätsklinikum Bonn | Bonn | 53127 | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| University Medicine Gottingen Germany | Göttingen | 37075 | Germany |
| Medizinische Hochschule Hannover, Innere Abteilung/Pneumologie | Hanover | 30625 | Germany |
| Universitatsklinikum Leipzig | Leipzig | 04103 | Germany |
| Universitatsklinikum Munster | Münster | 48149 | Germany |
| Augenzentrum am St Franziskus-Hospital | Münster | Germany |
| Universitatsklinikum Tubingen | Tübingen | 72076 | Germany |
| Rambam Medical Center - PPDS | Haifa | 3109600 | Israel |
| Tel Aviv Sourasky Medical Center PPDS | Jerusalem | 90000 | Israel |
| Hadassah Medical Center | Jerusalem | 91120 | Israel |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| Azienda Sanitaria Universitaria Friuli Centrale ? PO Universitario Santa Maria della Misericordia | Udine | Friuli Venezia Giulia | 33100 | Italy |
| Fondazione G.B. Bietti Per Lo Sudio E La Ricerca In Oftalmologia-Presidio Ospedaliero Britannico | Rome | Lazio | Italy |
| Ospedale S. Giuseppe Multimedica | Milan | Lombardy | 20123 | Italy |
| Ospedale San Raffaele S.r.l. - PPDS | Milan | Lombardy | 20132 | Italy |
| ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco | Milan | Lombardy | 20157 | Italy |
| Emanuelli Research and Development Center LLC | Arecibo | 00612 | Puerto Rico |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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