A Study of Disease Progression in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

NCT02399072 | Terminated

• 2 other identifiers: GX296392014-003940-11
• Study Type: observational
• Target: 202
• Locations: 12 countries
• Sites: 63

Brief Summary

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.

Conditions

Geographic Atrophy

Outcome Measures

Primary Outcomes (1)

• Mean Change from Baseline in the GA Area as Assessed by Fundus Autofluorescence (FAF) up to Month 60

  Baseline up to Month 60

Secondary Outcomes (12)

• 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

  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

Study Arms (1)

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.

Other: No intervention

Interventions

No intervention OTHER

No intervention administered in this study

Geographic Atrophy Participants

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (63)

Retina Specialty Institute

Pensacola, Florida, 32503, United States

Location

Midwest Vision Research Foundation

Chesterfield, Missouri, 63017, United States

Location

Char Eye Ear &Throat Assoc

Charlotte, North Carolina, 28210, United States

Location

Retina Assoc of Cleveland Inc

Cleveland, Ohio, 44122, United States

Location

Palmetto Retina Center

Florence, South Carolina, 29501, United States

Location

Tennessee Retina PC.

Nashville, Tennessee, 37203, United States

Location

Retina Res Institute of Texas

Abilene, Texas, 79606, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

Retina Consultants of Houston

The Woodlands, Texas, 77384, United States

Location

Strategic Clinical Research Group, LLC

Willow Park, Texas, 76087, United States

Location

West Virginia University Eye Institute

Morgantown, West Virginia, 26506, United States

Location

Organizacion Medica de Investigacion

Buenos Aires, C1015ABO, Argentina

Location

Oftalmos

Capital Federal, C1120AAN, Argentina

Location

Centro Privado de Ojos Romagosa

Córdoba, Argentina

Location

Onnis Instituto oftalmológico privado

Córdoba, Argentina

Location

Oftar

Mendoza, M5500GGK, Argentina

Location

Marsden Eye Research Centre

Parramatta, New South Wales, 2150, Australia

Location

Adelaide Eye and Retina Centre

Adelaide, South Australia, 5000, Australia

Location

Royal Victorian Eye and Ear Hospital

East Melbourne, Victoria, 3002, Australia

Location

The Lions Eye Institute

Nedlands, Western Australia, 6009, Australia

Location

Instituto da Visão IPEPO

São Paulo, São Paulo, 04038-032, Brazil

Location

Hosp Clinicas da FMUSP

São Paulo, São Paulo, 05403-000, Brazil

Location

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

Location

QEII - HSC Department of Ophthalmology

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Institut De L'Oeil Des Laurentides

Boisbriand, Quebec, J7H 1S6, Canada

Location

Hôpital Maisonneuve - Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Chi De Creteil; Ophtalmologie

Créteil, 94010, France

Location

CHU Bocage; Ophtalmologie

Dijon, 21079, France

Location

Hopital de la croix rousse; Ophtalmologie

Lyon, 69317, France

Location

Centre Paradis Monticelli; Ophtalmologie

Marseille, 13008, France

Location

Centre Odeon; Exploration Ophtalmologique

Paris, 75006, France

Location

Hopital Lariboisiere; Ophtalmologie

Paris, 75010, France

Location

CHNO des Quinze Vingts; Ophtalmologie

Paris, 75012, France

Location

CHU Poitiers - CHR La Miletrie; Ophtalmologie

Poitiers, 86021, France

Location

Centres Ophtalmologique St Exupéry; Ophtalmologie

Saint-Cyr-sur-Loire, 37540, France

Location

Universitäts-Augenklinik Bonn

Bonn, 53127, Germany

Location

Universitätsklinikum Köln; Augenklinik

Cologne, 50937, Germany

Location

Universitätsklinikum Münster; Augenheilkunde

Münster, 48149, Germany

Location

Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde

Regensburg, 93053, Germany

Location

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

Budapest, 1076, Hungary

Location

Semmelweis Egyetem AOK, Szemeszeti Klinika

Budapest, 1083, Hungary

Location

Budapest Retina Associates Kft.

Budapest, 1133, Hungary

Location

Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

Debrecem, 4032, Hungary

Location

Ganglion Medial Center

Pécs, 7621, Hungary

Location

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

Rome, Lazio, 00133, Italy

Location

ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

Milan, Lombardy, 20157, Italy

Location

OFTALMIKA Sp. z o.o

Bydgoszcz, 85-631, Poland

Location

Szpital Specjalistyczny nr 1; Oddzial Okulistyki

Bytom, 41-902, Poland

Location

Optimum Profesorskie Centrum Okulistyki

Gdansk, 80-809, Poland

Location

Gabinet Okulistyczny Prof Edward Wylegala

Katowice, 40-594, Poland

Location

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

Krakow, 31-501, Poland

Location

Klinika Okulistyczna Jasne Błonia

Lodz, 91-134, Poland

Location

SPEKTRUM Osrodek Okulistyki Klinicznej

Wroclaw, 53-334, Poland

Location

Hospital Universitari de Bellvitge; Servicio de Oftalmologia

L'Hospitalet de Llobregat, Barcelona, 8907, Spain

Location

Hospital General de Catalunya

San Cugat Del Valles, Barcelona, 08195, Spain

Location

Clinica Universitaria de Navarra; Servicio de Oftalmologia

Pamplona, Navarre, 31008, Spain

Location

Institut de la Macula i la retina

Barcelona, 08022, Spain

Location

Bradford Royal Infirmary

Bradford, BD9 6RJ, United Kingdom

Location

Bristol Eye Hospital

Bristol, BS1 2LX, United Kingdom

Location

Moorfields Eye Hospital NHS Foundation Trust

London, EC1V 2PD, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southhampton, SO16 6YD, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 39758130 DERIVED

• 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.

  PMID: 37517799 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.

  PMID: 37428131 DERIVED

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 26, 2015
• Study Start: March 30, 2015
• Primary Completion: February 8, 2018
• Study Completion: February 8, 2018
• Last Updated: August 9, 2019

Record last verified: 2019-08

Locations

FR (9); CA (6); AU (4); AR (5); US (11); BR (2); GB (4); ES (4); HU (5); DE (4); IT (2); PL (7)