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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003940-11 | EudraCT Number | ||
| GX29639 | Other Identifier | Hoffmann-La Roche ID |
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There is no longer a plan to pursue an approval of lampalizumab.
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This study seeks to better characterize relationships between visual function and the progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration (AMD). The study also will generate new information on the relationship between genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling 200 participants with GA secondary to AMD. The study visits are scheduled to occur every 6 months. The anticipated duration of the study is up to 60 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Geographic Atrophy Participants | Participants with unilateral GA or GA in one eye and choroidal neovascularization (CNV; active or treated) with or without GA, in the contralateral eye, will be evaluated for the progression of GA for up to approximately 60 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention administered in this study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in the GA Area as Assessed by Fundus Autofluorescence (FAF) up to Month 60 | Baseline up to Month 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart up to Month 60 | Baseline up to Month 60 | |
| Change from Baseline in BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions up to Month 60 |
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Inclusion Criteria:
Cohort 1: Participants with unilateral GA OR Cohort 2: Participants with GA in one eye and CNV (active or treated) with or without GA, in the contralateral eye
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Specialty Institute | Pensacola | Florida | 32503 | United States | ||
| Midwest Vision Research Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39758130 | Derived | Salvi A, Cluceru J, Gao SS, Rabe C, Schiffman C, Yang Q, Lee AY, Keane PA, Sadda SR, Holz FG, Ferrara D, Anegondi N. Deep Learning to Predict the Future Growth of Geographic Atrophy from Fundus Autofluorescence. Ophthalmol Sci. 2024 Oct 23;5(2):100635. doi: 10.1016/j.xops.2024.100635. eCollection 2025 Mar-Apr. | |
| 37517799 | Derived |
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| Baseline up to Month 60 |
| Change from Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Cards or Radner Reading Cards up to Month 60 | Baseline up to Month 60 |
| Change from Baseline in Monocular Reading Speed as Assessed by MNRead Cards or Radner Reading Cards up to Month 60 | Baseline up to Month 60 |
| Change from Baseline in Binocular Critical Print Size as Assessed by MNRead Cards or Radner Reading Cards up to Month 60 | Baseline up to Month 60 |
| Change from Baseline in Monocular Critical Print Size as Assessed by MNRead Cards or Radner Reading Cards up to Month 60 | Baseline up to Month 60 |
| Change from Baseline in Near Activity Subscale as Assessed by National Eye Institute Visual Functioning Questionnaire 25-Item Version (NEI VFQ-25) up to Month 60 | Baseline up to Month 60 |
| Change from Baseline in Distance Activity Subscale as Assessed by NEI VFQ-25 up to Month 60 | Baseline up to Month 60 |
| Change from Baseline in Composite Scores as Assessed by NEI VFQ-25 up to Month 60 | Baseline up to Month 60 |
| Change from Baseline in Functional Reading Independence Score up to Month 60 | Baseline up to Month 60 |
| Percentage of Participants With Medical Events | Baseline up to Month 60 |
| Percentage of Participants With Ocular Events | Baseline up to Month 60 |
| Chesterfield |
| Missouri |
| 63017 |
| United States |
| Char Eye Ear &Throat Assoc | Charlotte | North Carolina | 28210 | United States |
| Retina Assoc of Cleveland Inc | Cleveland | Ohio | 44122 | United States |
| Palmetto Retina Center | Florence | South Carolina | 29501 | United States |
| Tennessee Retina PC. | Nashville | Tennessee | 37203 | United States |
| Retina Res Institute of Texas | Abilene | Texas | 79606 | United States |
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
| Retina Consultants of Houston | The Woodlands | Texas | 77384 | United States |
| Strategic Clinical Research Group, LLC | Willow Park | Texas | 76087 | United States |
| West Virginia University Eye Institute | Morgantown | West Virginia | 26506 | United States |
| Organizacion Medica de Investigacion | Buenos Aires | C1015ABO | Argentina |
| Oftalmos | Capital Federal | C1120AAN | Argentina |
| Centro Privado de Ojos Romagosa | Córdoba | Argentina |
| Onnis Instituto oftalmológico privado | Córdoba | Argentina |
| Oftar | Mendoza | M5500GGK | Argentina |
| Marsden Eye Research Centre | Parramatta | New South Wales | 2150 | Australia |
| Adelaide Eye and Retina Centre | Adelaide | South Australia | 5000 | Australia |
| Royal Victorian Eye and Ear Hospital | East Melbourne | Victoria | 3002 | Australia |
| The Lions Eye Institute | Nedlands | Western Australia | 6009 | Australia |
| Instituto da Visão IPEPO | São Paulo | São Paulo | 04038-032 | Brazil |
| Hosp Clinicas da FMUSP | São Paulo | São Paulo | 05403-000 | Brazil |
| University of British Columbia | Vancouver | British Columbia | V6T 1Z4 | Canada |
| QEII - HSC Department of Ophthalmology | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| University Health Network Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| Institut De L'Oeil Des Laurentides | Boisbriand | Quebec | J7H 1S6 | Canada |
| Hôpital Maisonneuve - Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| Chi De Creteil; Ophtalmologie | Créteil | 94010 | France |
| CHU Bocage; Ophtalmologie | Dijon | 21079 | France |
| Hopital de la croix rousse; Ophtalmologie | Lyon | 69317 | France |
| Centre Paradis Monticelli; Ophtalmologie | Marseille | 13008 | France |
| Centre Odeon; Exploration Ophtalmologique | Paris | 75006 | France |
| Hopital Lariboisiere; Ophtalmologie | Paris | 75010 | France |
| CHNO des Quinze Vingts; Ophtalmologie | Paris | 75012 | France |
| CHU Poitiers - CHR La Miletrie; Ophtalmologie | Poitiers | 86021 | France |
| Centres Ophtalmologique St Exupéry; Ophtalmologie | Saint-Cyr-sur-Loire | 37540 | France |
| Universitäts-Augenklinik Bonn | Bonn | 53127 | Germany |
| Universitätsklinikum Köln; Augenklinik | Cologne | 50937 | Germany |
| Universitätsklinikum Münster; Augenheilkunde | Münster | 48149 | Germany |
| Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde | Regensburg | 93053 | Germany |
| Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR | Budapest | 1076 | Hungary |
| Semmelweis Egyetem AOK, Szemeszeti Klinika | Budapest | 1083 | Hungary |
| Budapest Retina Associates Kft. | Budapest | 1133 | Hungary |
| Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika | Debrecem | 4032 | Hungary |
| Ganglion Medial Center | Pécs | 7621 | Hungary |
| Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche | Rome | Lazio | 00133 | Italy |
| ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco) | Milan | Lombardy | 20157 | Italy |
| OFTALMIKA Sp. z o.o | Bydgoszcz | 85-631 | Poland |
| Szpital Specjalistyczny nr 1; Oddzial Okulistyki | Bytom | 41-902 | Poland |
| Optimum Profesorskie Centrum Okulistyki | Gdansk | 80-809 | Poland |
| Gabinet Okulistyczny Prof Edward Wylegala | Katowice | 40-594 | Poland |
| SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej | Krakow | 31-501 | Poland |
| Klinika Okulistyczna Jasne Błonia | Lodz | 91-134 | Poland |
| SPEKTRUM Osrodek Okulistyki Klinicznej | Wroclaw | 53-334 | Poland |
| Hospital Universitari de Bellvitge; Servicio de Oftalmologia | L'Hospitalet de Llobregat | Barcelona | 8907 | Spain |
| Hospital General de Catalunya | San Cugat Del Valles | Barcelona | 08195 | Spain |
| Clinica Universitaria de Navarra; Servicio de Oftalmologia | Pamplona | Navarre | 31008 | Spain |
| Institut de la Macula i la retina | Barcelona | 08022 | Spain |
| Bradford Royal Infirmary | Bradford | BD9 6RJ | United Kingdom |
| Bristol Eye Hospital | Bristol | BS1 2LX | United Kingdom |
| Moorfields Eye Hospital NHS Foundation Trust | London | EC1V 2PD | United Kingdom |
| University Hospital Southampton NHS Foundation Trust | Southhampton | SO16 6YD | United Kingdom |
| Schmitz-Valckenberg S, Sassmannshausen M, Braun M, Steffen V, Gao SS, Honigberg L, Ferrara D, Pfau M, Holz FG. Interreader Agreement and Longitudinal Progression of Incomplete/Complete Retinal Pigment Epithelium and Outer Retinal Atrophy in Age-Related Macular Degeneration. Ophthalmol Retina. 2023 Dec;7(12):1059-1068. doi: 10.1016/j.oret.2023.07.021. Epub 2023 Jul 29. |
| 37428131 | Derived | Spaide T, Jiang J, Patil J, Anegondi N, Steffen V, Kawczynski MG, Newton EM, Rabe C, Gao SS, Lee AY, Holz FG, Sadda S, Schmitz-Valckenberg S, Ferrara D. Geographic Atrophy Segmentation Using Multimodal Deep Learning. Transl Vis Sci Technol. 2023 Jul 3;12(7):10. doi: 10.1167/tvst.12.7.10. |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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