A Study of Disease Progression in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 202
- 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
- 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