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

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-30

Study Completion Date

2018-02-08

Brief Summary

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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.

Detailed Description

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Conditions

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Geographic Atrophy

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

Intervention Type OTHER

No intervention administered in this study

Interventions

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No intervention

No intervention administered in this study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Well-demarcated area of GA secondary to AMD
* 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

* Previous participation in any studies of investigational drugs for GA / dry AMD (exception for studies of vitamins and minerals)
* 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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Midwest Vision Research Foundation

Chesterfield, Missouri, United States

Site Status

Char Eye Ear &Throat Assoc

Charlotte, North Carolina, United States

Site Status

Retina Assoc of Cleveland Inc

Cleveland, Ohio, United States

Site Status

Palmetto Retina Center

Florence, South Carolina, United States

Site Status

Tennessee Retina PC.

Nashville, Tennessee, United States

Site Status

Retina Res Institute of Texas

Abilene, Texas, United States

Site Status

Texas Retina Associates

Dallas, Texas, United States

Site Status

Retina Consultants of Houston

The Woodlands, Texas, United States

Site Status

Strategic Clinical Research Group, LLC

Willow Park, Texas, United States

Site Status

West Virginia University Eye Institute

Morgantown, West Virginia, United States

Site Status

Organizacion Medica de Investigacion

Buenos Aires, , Argentina

Site Status

Oftalmos

Capital Federal, , Argentina

Site Status

Centro Privado de Ojos Romagosa

Córdoba, , Argentina

Site Status

Onnis Instituto oftalmológico privado

Córdoba, , Argentina

Site Status

Oftar

Mendoza, , Argentina

Site Status

Marsden Eye Research Centre

Parramatta, New South Wales, Australia

Site Status

Adelaide Eye and Retina Centre

Adelaide, South Australia, Australia

Site Status

Royal Victorian Eye and Ear Hospital

East Melbourne, Victoria, Australia

Site Status

The Lions Eye Institute

Nedlands, Western Australia, Australia

Site Status

Instituto da Visão IPEPO

São Paulo, São Paulo, Brazil

Site Status

Hosp Clinicas da FMUSP

São Paulo, São Paulo, Brazil

Site Status

University of British Columbia

Vancouver, British Columbia, Canada

Site Status

QEII - HSC Department of Ophthalmology

Halifax, Nova Scotia, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

University Health Network Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Institut De L'Oeil Des Laurentides

Boisbriand, Quebec, Canada

Site Status

Hôpital Maisonneuve - Rosemont

Montreal, Quebec, Canada

Site Status

Chi De Creteil; Ophtalmologie

Créteil, , France

Site Status

CHU Bocage; Ophtalmologie

Dijon, , France

Site Status

Hopital de la croix rousse; Ophtalmologie

Lyon, , France

Site Status

Centre Paradis Monticelli; Ophtalmologie

Marseille, , France

Site Status

Centre Odeon; Exploration Ophtalmologique

Paris, , France

Site Status

Hopital Lariboisiere; Ophtalmologie

Paris, , France

Site Status

CHNO des Quinze Vingts; Ophtalmologie

Paris, , France

Site Status

CHU Poitiers - CHR La Miletrie; Ophtalmologie

Poitiers, , France

Site Status

Centres Ophtalmologique St Exupéry; Ophtalmologie

Saint-Cyr-sur-Loire, , France

Site Status

Universitäts-Augenklinik Bonn

Bonn, , Germany

Site Status

Universitätsklinikum Köln; Augenklinik

Cologne, , Germany

Site Status

Universitätsklinikum Münster; Augenheilkunde

Münster, , Germany

Site Status

Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde

Regensburg, , Germany

Site Status

Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR

Budapest, , Hungary

Site Status

Semmelweis Egyetem AOK, Szemeszeti Klinika

Budapest, , Hungary

Site Status

Budapest Retina Associates Kft.

Budapest, , Hungary

Site Status

Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

Debrecem, , Hungary

Site Status

Ganglion Medial Center

Pécs, , Hungary

Site Status

Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

Rome, Lazio, Italy

Site Status

ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

Milan, Lombardy, Italy

Site Status

OFTALMIKA Sp. z o.o

Bydgoszcz, , Poland

Site Status

Szpital Specjalistyczny nr 1; Oddzial Okulistyki

Bytom, , Poland

Site Status

Optimum Profesorskie Centrum Okulistyki

Gdansk, , Poland

Site Status

Gabinet Okulistyczny Prof Edward Wylegala

Katowice, , Poland

Site Status

SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

Krakow, , Poland

Site Status

Klinika Okulistyczna Jasne Błonia

Lodz, , Poland

Site Status

SPEKTRUM Osrodek Okulistyki Klinicznej

Wroclaw, , Poland

Site Status

Hospital Universitari de Bellvitge; Servicio de Oftalmologia

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Hospital General de Catalunya

San Cugat Del Valles, Barcelona, Spain

Site Status

Clinica Universitaria de Navarra; Servicio de Oftalmologia

Pamplona, Navarre, Spain

Site Status

Institut de la Macula i la retina

Barcelona, , Spain

Site Status

Bradford Royal Infirmary

Bradford, , United Kingdom

Site Status

Bristol Eye Hospital

Bristol, , United Kingdom

Site Status

Moorfields Eye Hospital NHS Foundation Trust

London, , United Kingdom

Site Status

University Hospital Southampton NHS Foundation Trust

Southhampton, , United Kingdom

Site Status

Countries

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United States Argentina Australia Brazil Canada France Germany Hungary Italy Poland Spain United Kingdom

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.

Reference Type DERIVED
PMID: 39758130 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37517799 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37428131 (View on PubMed)

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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