A Study of Disease Progression in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
NCT ID: NCT02399072
Last Updated: 2019-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
202 participants
OBSERVATIONAL
2015-03-30
2018-02-08
Brief Summary
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Detailed Description
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Conditions
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Study Groups
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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.
No intervention
No intervention administered in this study
Interventions
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No intervention
No intervention administered in this study
Eligibility Criteria
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Inclusion Criteria
* Women of childbearing potential and men must agree to use adequate contraception for at least 30 days after fluorescein dye administration
* The study is recruiting participants in two different cohorts:
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
* GA in either eye due to causes other than AMD
* History of vitrectomy surgery, submacular surgery, or any surgical intervention for AMD
* Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and/or proliferative diabetic retinopathy
* Any ocular/systemic medical conditions that, in the opinion of the investigator, could contribute to participant's inability to participate in the study or interfere with study assessments.
* Requirement for continuous use of therapy indicated in Prohibited Therapy
50 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Retina Specialty Institute
Pensacola, Florida, United States
Midwest Vision Research Foundation
Chesterfield, Missouri, United States
Char Eye Ear &Throat Assoc
Charlotte, North Carolina, United States
Retina Assoc of Cleveland Inc
Cleveland, Ohio, United States
Palmetto Retina Center
Florence, South Carolina, United States
Tennessee Retina PC.
Nashville, Tennessee, United States
Retina Res Institute of Texas
Abilene, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
Retina Consultants of Houston
The Woodlands, Texas, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, United States
West Virginia University Eye Institute
Morgantown, West Virginia, United States
Organizacion Medica de Investigacion
Buenos Aires, , Argentina
Oftalmos
Capital Federal, , Argentina
Centro Privado de Ojos Romagosa
Córdoba, , Argentina
Onnis Instituto oftalmológico privado
Córdoba, , Argentina
Oftar
Mendoza, , Argentina
Marsden Eye Research Centre
Parramatta, New South Wales, Australia
Adelaide Eye and Retina Centre
Adelaide, South Australia, Australia
Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, Australia
The Lions Eye Institute
Nedlands, Western Australia, Australia
Instituto da Visão IPEPO
São Paulo, São Paulo, Brazil
Hosp Clinicas da FMUSP
São Paulo, São Paulo, Brazil
University of British Columbia
Vancouver, British Columbia, Canada
QEII - HSC Department of Ophthalmology
Halifax, Nova Scotia, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
University Health Network Toronto Western Hospital
Toronto, Ontario, Canada
Institut De L'Oeil Des Laurentides
Boisbriand, Quebec, Canada
Hôpital Maisonneuve - Rosemont
Montreal, Quebec, Canada
Chi De Creteil; Ophtalmologie
Créteil, , France
CHU Bocage; Ophtalmologie
Dijon, , France
Hopital de la croix rousse; Ophtalmologie
Lyon, , France
Centre Paradis Monticelli; Ophtalmologie
Marseille, , France
Centre Odeon; Exploration Ophtalmologique
Paris, , France
Hopital Lariboisiere; Ophtalmologie
Paris, , France
CHNO des Quinze Vingts; Ophtalmologie
Paris, , France
CHU Poitiers - CHR La Miletrie; Ophtalmologie
Poitiers, , France
Centres Ophtalmologique St Exupéry; Ophtalmologie
Saint-Cyr-sur-Loire, , France
Universitäts-Augenklinik Bonn
Bonn, , Germany
Universitätsklinikum Köln; Augenklinik
Cologne, , Germany
Universitätsklinikum Münster; Augenheilkunde
Münster, , Germany
Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde
Regensburg, , Germany
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
Budapest, , Hungary
Semmelweis Egyetem AOK, Szemeszeti Klinika
Budapest, , Hungary
Budapest Retina Associates Kft.
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
Debrecem, , Hungary
Ganglion Medial Center
Pécs, , Hungary
Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
Rome, Lazio, Italy
ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
Milan, Lombardy, Italy
OFTALMIKA Sp. z o.o
Bydgoszcz, , Poland
Szpital Specjalistyczny nr 1; Oddzial Okulistyki
Bytom, , Poland
Optimum Profesorskie Centrum Okulistyki
Gdansk, , Poland
Gabinet Okulistyczny Prof Edward Wylegala
Katowice, , Poland
SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej
Krakow, , Poland
Klinika Okulistyczna Jasne Błonia
Lodz, , Poland
SPEKTRUM Osrodek Okulistyki Klinicznej
Wroclaw, , Poland
Hospital Universitari de Bellvitge; Servicio de Oftalmologia
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital General de Catalunya
San Cugat Del Valles, Barcelona, Spain
Clinica Universitaria de Navarra; Servicio de Oftalmologia
Pamplona, Navarre, Spain
Institut de la Macula i la retina
Barcelona, , Spain
Bradford Royal Infirmary
Bradford, , United Kingdom
Bristol Eye Hospital
Bristol, , United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southhampton, , United Kingdom
Countries
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References
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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.
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.
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.
Other Identifiers
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2014-003940-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GX29639
Identifier Type: OTHER
Identifier Source: secondary_id
GX29639
Identifier Type: -
Identifier Source: org_study_id
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