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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003939-19 | 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 is also intended to generate new information on the relationship between genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling 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 48 months. There is a planned interim analysis around the 2-year time window for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort Geographic Atrophy | Cohort of participants with GA secondary to AMD will be evaluated for changes in GA over time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention was administered in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Scotomatous Points as Assessed by Mesopic Microperimetry (MP) | Baseline up to end of study (up to approximately 48 months) | |
| Macular Sensitivity as Assessed by Mesopic MP | Baseline up to end of study (up to approximately 48 months) | |
| Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart | Baseline up to end of study (up to approximately 48 months) | |
| BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions | Baseline up to end of study (up to approximately 48 months) | |
| Monocular and Binocular Reading Speed as Assessed by the Minnesota Low-Vision Reading Test (MNRead) or by Radner Reading Cards | Baseline up to end of study (up to approximately 48 months) | |
| Monocular and Binocular Critical Print Size as Assessed by the MNRead or by Radner Reading Cards | Baseline up to end of study (up to approximately 48 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the GA area, as Assessed by Fundus Autofluorescence (FAF) | Baseline, end of study (up to approximately 48 months) | |
| Change from Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Version (NEI VFQ-25) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwest Arkansas Retina Associates | Springdale | Arkansas | 72764 | United States | ||
| Retinal Diagnostic Center |
| 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. | |
| 39581330 | Derived |
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| Baseline, end of study (up to approximately 48 months) |
| Change from Baseline in Functional Reading Independence (FRI) Index Score | Baseline, end of study (up to approximately 48 months) |
| Percentage of Participants With Medical Events of Interest (MEIs) | The clinical events (cardiovascular, respiratory, cognitive, ocular events etc.) occurring during the study are termed as MEIs. These events will be collected using MEI electronic Case Report Form (eCRF) checklist. | Baseline up to end of study (up to approximately 48 months) |
| Campbell |
| California |
| 95008 |
| United States |
| Specialty Eye Care Medical Center | Glendale | California | 91203 | United States |
| Jules Stein Eye Institute/ UCLA | Los Angeles | California | 90095-7000 | United States |
| East Bay Retina Consultants | Oakland | California | 94609 | United States |
| Colorado Retina Associates, PC | Golden | Colorado | 80401 | United States |
| Rand Eye | Deerfield Beach | Florida | 33064 | United States |
| Bascom Palmer Eye Institute | Naples | Florida | 34103 | United States |
| Center For Sight | Sarasota | Florida | 34239 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Paducah Retinal Center | Paducah | Kentucky | 42001 | United States |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | United States |
| Foundation for Vision Research | Grand Rapids | Michigan | 49546 | United States |
| MaculaCare, PLLC | New York | New York | 10021 | United States |
| Vitreous-Retina-Macula | New York | New York | 10022 | United States |
| University of North Carolina; Kittner Eye Center | Chapel Hill | North Carolina | 27517 | United States |
| Char Eye Ear &Throat Assoc | Charlotte | North Carolina | 28210 | United States |
| Duke University Eye Center; Vitreoretinal | Durham | North Carolina | 27710 | United States |
| Scheie Eye Institute | Philadelphia | Pennsylvania | 19104 | United States |
| Palmetto Retina Center | Florence | South Carolina | 29501 | United States |
| Retina Consultants of Houston | Houston | Texas | 77030 | United States |
| Med Center Ophthalmology Assoc | San Antonio | Texas | 78240 | United States |
| Wagner Macula & Retina Center | Norfolk | Virginia | 23451 | 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 |
| Clinica Privada de Ojos | Mar del Plata | B7600DFC | Argentina |
| Centro Oftalmólogos Especialistas | Rosario | S2000ANJ | Argentina |
| Northern Beaches Retina Cataract Glaucoma | Mona Vale | New South Wales | 2103 | Australia |
| Strathfield Retina Clinic | Strathfield | New South Wales | 2135 | Australia |
| Newcastle Eye Hospital Research Foundation | Waratah | New South Wales | 2298 | Australia |
| Royal Victorian Eye and Ear Hospital | East Melbourne | Victoria | 3002 | Australia |
| The Lions Eye Institute | Nedlands | Western Australia | 6009 | Australia |
| Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie | Vienna | 1090 | Austria |
| Hospital de Olhos de Aparecida - HOA | Aparecida de Goiânia | Goiás | 74980-010 | Brazil |
| Instituto da Visão | Belo Horizonte | Minas Gerais | 30150-270 | Brazil |
| Botelho Hospital da Visao | Blumenau | Santa Catarina | 89052-504 | Brazil |
| Instituto da Visão IPEPO | São Paulo | São Paulo | 04038-032 | Brazil |
| Hosp Clinicas da FMUSP | São Paulo | São Paulo | 05403-000 | Brazil |
| Calgary Retina Consultants | Calgary | Alberta | T2J 0C8 | Canada |
| Institut De L'Oeil Des Laurentides | Boisbriand | Quebec | J7H 1S6 | Canada |
| Chi De Creteil; Ophtalmologie | Créteil | 94010 | France |
| Clinique de la Louviere - Nord retine; Maladie et chirurgie des Yeux | Lille | 59000 | France |
| Centre ophtalmologique Rabelais; Ophtalmologie | Lyon | 69003 | France |
| Centre Paradis Monticelli; Ophtalmologie | Marseille | 13008 | France |
| Hopital Lariboisiere; Ophtalmologie | Paris | 75010 | France |
| CHNO des Quinze Vingts; Ophtalmologie | Paris | 75012 | France |
| Fondation Rothschild; Ophtalmologie | Paris | 75940 | France |
| CHU Poitiers - CHR La Miletrie; Ophtalmologie | Poitiers | 86021 | France |
| Centres Ophtalmologique St Exupéry; Ophtalmologie | Saint-Cyr-sur-Loire | 37540 | France |
| Cabinet La Maison Rouge; Ophtalmologie | Strasbourg | 67000 | France |
| Universitatsklinikum Leipzig | Leipzig | 04103 | Germany |
| Klinikum rechts der Isar der TU München; Augenklinik | München | 81675 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| University General Hospital of Heraklion; Department of Ophthalmology | Heraklion | 711 10 | Greece |
| European Interbalkan Medical Center; Ophthalmology Dpt | Thessaloniki | 57001 | Greece |
| Bajcsy-Zsilinszky Hospital | Budapest | 1106 | Hungary |
| Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely | Budapest | H-1077 | Hungary |
| Kenezy Gyula Korhaz; Szemeszet | Debrecen | 4031 | Hungary |
| Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET | Szombathely | 9700 | Hungary |
| Soroka university medical center; Ophtalmology | Beersheba | 8489501 | Israel |
| Rambam Health Care Campus | Haifa | 3109600 | Israel |
| Hadassah MC; Ophtalmology | Jerusalem | 9112001 | Israel |
| Meir Medical Center; Ophtalmology | Kfar Saba | 4428164 | Israel |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 5265601 | Israel |
| Kaplan Medical Center; Ophtalmology | Rehovot | 7660101 | Israel |
| Tel Aviv Sourasky MC; Ophtalmology | Tel Aviv | 6423906 | Israel |
| Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche | Naples | Campania | 80131 | Italy |
| ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco) | Milan | Lombardy | 20157 | Italy |
| Università degli Studi dell'Insubria; Clinica Oculistica | Varese | Lombardy | 21100 | Italy |
| Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica | Florence | Tuscany | 50134 | Italy |
| Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria | Pisa | Tuscany | 56124 | Italy |
| Ospedale Classificato Equiparato Sacro Cuore - Don Calabria; Dipartimento Oculistica | Negrar - Verona | Veneto | 37024 | Italy |
| Klinika Okulistyki Ogolnej w Lublinie | Lublin | 20-079 | Poland |
| Pomorski Uniwersytet Medyczny w Szczecinie, Zaklad Patologii Ogolnej PUM" | Szczecin | 70-111 | Poland |
| SPEKTRUM Osrodek Okulistyki Klinicznej | Wroclaw | 53-334 | Poland |
| Institut de la Macula i la retina | Barcelona | 08022 | Spain |
| Hospital de la Santa Creu i Sant Pau; Servicio de Oftalmologia | Barcelona | 8025 | Spain |
| Hospital Universitario Virgen de la Macarena; Servicio de Oftalmologia | Seville | 41007 | Spain |
| Clinica Doctores Piñero; Oftalmologia | Seville | 41013 | Spain |
| Hospital Clinico Universitario de Valladolid; Servicio de oftalmologia | Valladolid | 47005 | Spain |
| Hospital Universitario Rio Hortega; Servicio de Oftalmologia | Valladolid | 47012 | Spain |
| Bristol Eye Hospital | Bristol | BS1 2LX | United Kingdom |
| Kent & Canterbury Hospital | Canterbury | CT1 3NG | United Kingdom |
| Hull and East Yorkshire Eye Hospital | Hull | HU32J | United Kingdom |
| John Radcliffe Hospital; Oxford Eye Hospital | Oxford | OX3 9DU | United Kingdom |
| University Hospital Southampton NHS Foundation Trust | Southhampton | SO16 6YD | United Kingdom |
| Sunderland Eye Infirmary | Sunderland | SR2 9HP | United Kingdom |
| Pinderfields Hospital; Clinical Research Team, Rowan House | Wakefield | WF1 4DG | United Kingdom |
| Anegondi N, Steffen V, Sadda SR, Schmitz-Valckenberg S, Tufail A, Csaky K, Lad EM, Kaiser PK, Ferrara D, Chakravarthy U. Visual Loss in Geographic Atrophy: Learnings from the Lampalizumab Trials. Ophthalmology. 2025 Apr;132(4):420-430. doi: 10.1016/j.ophtha.2024.11.017. Epub 2024 Nov 23. |
| 39102242 | Derived | Cluceru J, Anegondi N, Gao SS, Lee AY, Lad EM, Chakravarthy U, Yang Q, Steffen V, Friesenhahn M, Rabe C, Ferrara D. Topographic Clinical Insights From Deep Learning-Based Geographic Atrophy Progression Prediction. Transl Vis Sci Technol. 2024 Aug 1;13(8):6. doi: 10.1167/tvst.13.8.6. |
| 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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