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

Terminated

• Conditions: Geographic Atrophy
• Interventions: Other: No intervention

• Registration Number: NCT02399072
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-26
• Study Start: 2015-03-30
• Primary Completion: 2018-02-08
• Study Completion: 2018-02-08
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-07
• Last Update Posted: 2019-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 202

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Geographic Atrophy Participants	No intervention	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 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
Percentage of Participants With Medical Events	Baseline up to Month 60
Percentage of Participants With Ocular Events	Baseline up to Month 60
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 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

Trial Locations

Locations (63)

Midwest Vision Research Foundation; 🇺🇸 Chesterfield, Missouri, United States

Retina Consultants of Houston; 🇺🇸 The Woodlands, Texas, United States

Retina Assoc of Cleveland Inc; 🇺🇸 Cleveland, Ohio, United States

Szpital Specjalistyczny nr 1; Oddzial Okulistyki; 🇵🇱 Bytom, Poland

Char Eye Ear &Throat Assoc; 🇺🇸 Charlotte, North Carolina, United States

West Virginia University Eye Institute; 🇺🇸 Morgantown, West Virginia, United States

Palmetto Retina Center; 🇺🇸 Florence, South Carolina, United States

Retina Res Institute of Texas; 🇺🇸 Abilene, Texas, United States

Texas Retina Associates; 🇺🇸 Dallas, Texas, United States

Organizacion Medica de Investigacion; 🇦🇷 Buenos Aires, Argentina

The Lions Eye Institute; 🇦🇺 Nedlands, Western Australia, Australia

Oftalmos; 🇦🇷 Capital Federal, Argentina

Onnis Instituto oftalmológico privado; 🇦🇷 Cordoba, Argentina

Marsden Eye Research Centre; 🇦🇺 Parramatta, New South Wales, Australia

Oftar; 🇦🇷 Mendoza, Argentina

Adelaide Eye and Retina Centre; 🇦🇺 Adelaide, South Australia, Australia

Royal Victorian Eye and Ear Hospital; 🇦🇺 East Melbourne, Victoria, Australia

Instituto da Visão IPEPO; 🇧🇷 Sao Paulo, SP, Brazil

Hosp Clinicas da FMUSP; 🇧🇷 Sao Paulo, SP, Brazil

Gabinet Okulistyczny Prof Edward Wylegala; 🇵🇱 Katowice, Poland

Optimum Profesorskie Centrum Okulistyki; 🇵🇱 Gdańsk, Poland

SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej; 🇵🇱 Krakow, Poland

SPEKTRUM Osrodek Okulistyki Klinicznej; 🇵🇱 Wroclaw, Poland

Klinika Okulistyczna Jasne Błonia; 🇵🇱 Łódź, Poland

Hospital General de Catalunya; 🇪🇸 San Cugat Del Valles, Barcelona, Spain

Bradford Royal Infirmary; 🇬🇧 Bradford, United Kingdom

Bristol Eye Hospital; 🇬🇧 Bristol, United Kingdom

Tennessee Retina PC.; 🇺🇸 Nashville, Tennessee, United States

Moorfields Eye Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

University Hospital Southampton NHS Foundation Trust; 🇬🇧 Southhampton, United Kingdom

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

University Health Network Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

Hospital Universitari de Bellvitge; Servicio de Oftalmologia; 🇪🇸 Hospitalet De Llobregat, Barcelona, Spain

Institut de la Macula i la retina; 🇪🇸 Barcelona, Spain

Retina Specialty Institute; 🇺🇸 Pensacola, Florida, United States

CHNO des Quinze Vingts; Ophtalmologie; 🇫🇷 Paris, France

Strategic Clinical Research Group, LLC; 🇺🇸 Willow Park, Texas, United States

Centro Privado de Ojos Romagosa; 🇦🇷 Cordoba, Argentina

QEII - HSC Department of Ophthalmology; 🇨🇦 Halifax, Nova Scotia, Canada

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

Hôpital Maisonneuve - Rosemont; 🇨🇦 Montreal, Quebec, Canada

CHU Bocage; Ophtalmologie; 🇫🇷 Dijon, France

Hopital de la croix rousse; Ophtalmologie; 🇫🇷 Lyon cedex, France

Institut De L'Oeil Des Laurentides; 🇨🇦 Boisbriand, Quebec, Canada

Chi De Creteil; Ophtalmologie; 🇫🇷 Creteil, France

Hopital Lariboisiere; Ophtalmologie; 🇫🇷 Paris, France

Centre Paradis Monticelli; Ophtalmologie; 🇫🇷 Marseille, France

Universitäts-Augenklinik Bonn; 🇩🇪 Bonn, Germany

Centre Odeon; Exploration Ophtalmologique; 🇫🇷 Paris, France

Centres Ophtalmologique St Exupéry; Ophtalmologie; 🇫🇷 St Cyr Sur Loire, France

CHU Poitiers - CHR La Miletrie; Ophtalmologie; 🇫🇷 Poitiers, France

Semmelweis Egyetem AOK, Szemeszeti Klinika; 🇭🇺 Budapest, Hungary

Universitätsklinikum Köln; Augenklinik; 🇩🇪 Köln, Germany

Universitätsklinikum Münster; Augenheilkunde; 🇩🇪 Münster, Germany

Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde; 🇩🇪 Regensburg, Germany

Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche; 🇮🇹 Roma, Lazio, Italy

Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika; 🇭🇺 Debrecem, Hungary

Ganglion Medial Center; 🇭🇺 Pecs, Hungary

Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR; 🇭🇺 Budapest, Hungary

Budapest Retina Associates Kft.; 🇭🇺 Budapest, Hungary

ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco); 🇮🇹 Milano, Lombardia, Italy

OFTALMIKA Sp. z o.o; 🇵🇱 Bydgoszcz, Poland

Clinica Universitaria de Navarra; Servicio de Oftalmologia; 🇪🇸 Pamplona, Navarra, Spain