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
- NCT02479386
- 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 is also intended to generate new information on the relationship between genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling 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 48 months. There is a planned interim analysis around the 2-year time window for the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 296
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than (<) 1 percent (%) per year for at least 30 days after the last fluorescein dye administration
- The study is being conducted in participants with GA in both Study Eye and Non-Study Eye (bilateral GA) with no evidence of prior or active choroidal neovascularization (CNV)
- Previous participation in any studies of investigational drugs for GA or dry AMD (except 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 or 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 in the study Protocol
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort Geographic Atrophy No intervention Cohort of participants with GA secondary to AMD will be evaluated for changes in GA over time.
- Primary Outcome Measures
Name Time Method Monocular and Binocular Critical Print Size as Assessed by the MNRead or by Radner Reading Cards Baseline up to end of study (up to approximately 48 months) Number of Scotomatous Points as Assessed by Mesopic Microperimetry (MP) Baseline up to end of study (up to approximately 48 months) Macular Sensitivity as Assessed by Mesopic MP Baseline up to end of study (up to approximately 48 months) Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart Baseline up to end of study (up to approximately 48 months) BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions Baseline up to end of study (up to approximately 48 months) Monocular and Binocular Reading Speed as Assessed by the Minnesota Low-Vision Reading Test (MNRead) or by Radner Reading Cards Baseline up to end of study (up to approximately 48 months)
- Secondary Outcome Measures
Name Time Method Change from Baseline in the GA area, as Assessed by Fundus Autofluorescence (FAF) Baseline, end of study (up to approximately 48 months) Change from Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Version (NEI VFQ-25) Score Baseline, end of study (up to approximately 48 months) Change from Baseline in Functional Reading Independence (FRI) Index Score Baseline, end of study (up to approximately 48 months) Percentage of Participants With Medical Events of Interest (MEIs) Baseline up to end of study (up to approximately 48 months) The clinical events (cardiovascular, respiratory, cognitive, ocular events etc.) occurring during the study are termed as MEIs. These events will be collected using MEI electronic Case Report Form (eCRF) checklist.
Trial Locations
- Locations (91)
Klinika Okulistyki Ogolnej w Lublinie
🇵🇱Lublin, Poland
SPEKTRUM Osrodek Okulistyki Klinicznej
🇵🇱Wroclaw, Poland
Northwest Arkansas Retina Associates
🇺🇸Springdale, Arkansas, United States
Retinal Diagnostic Center
🇺🇸Campbell, California, United States
Specialty Eye Care Medical Center
🇺🇸Glendale, California, United States
Rand Eye
🇺🇸Deerfield Beach, Florida, United States
Center For Sight
🇺🇸Sarasota, Florida, United States
Colorado Retina Associates, PC
🇺🇸Golden, Colorado, United States
Jules Stein Eye Institute/ UCLA
🇺🇸Los Angeles, California, United States
East Bay Retina Consultants
🇺🇸Oakland, California, United States
Bascom Palmer Eye Institute
🇺🇸Naples, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Paducah Retinal Center
🇺🇸Paducah, Kentucky, United States
Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, United States
Foundation for Vision Research
🇺🇸Grand Rapids, Michigan, United States
MaculaCare, PLLC
🇺🇸New York, New York, United States
Vitreous-Retina-Macula
🇺🇸New York, New York, United States
University of North Carolina; Kittner Eye Center
🇺🇸Chapel Hill, North Carolina, United States
Scheie Eye Institute
🇺🇸Philadelphia, Pennsylvania, United States
Palmetto Retina Center
🇺🇸Florence, South Carolina, United States
Char Eye Ear &Throat Assoc
🇺🇸Charlotte, North Carolina, United States
Oftalmos
🇦🇷Capital Federal, Argentina
Centro Privado de Ojos Romagosa
🇦🇷Cordoba, Argentina
Organizacion Medica de Investigacion
🇦🇷Buenos Aires, Argentina
Wagner Macula & Retina Center
🇺🇸Norfolk, Virginia, United States
Clinica Privada de Ojos
🇦🇷Mar del Plata, Argentina
Onnis Instituto oftalmológico privado
🇦🇷Cordoba, Argentina
Centro Oftalmólogos Especialistas
🇦🇷Rosario, Argentina
Northern Beaches Retina Cataract Glaucoma
🇦🇺Mona Vale, New South Wales, Australia
Strathfield Retina Clinic
🇦🇺Strathfield, New South Wales, Australia
Newcastle Eye Hospital Research Foundation
🇦🇺Waratah, New South Wales, Australia
Royal Victorian Eye and Ear Hospital
🇦🇺East Melbourne, Victoria, Australia
The Lions Eye Institute
🇦🇺Nedlands, Western Australia, Australia
Hospital de Olhos de Aparecida - HOA
🇧🇷Aparecida de Goiania, GO, Brazil
Instituto da Visão
🇧🇷Belo Horizonte, MG, Brazil
Instituto da Visão IPEPO
🇧🇷Sao Paulo, SP, Brazil
Hosp Clinicas da FMUSP
🇧🇷Sao Paulo, SP, Brazil
Calgary Retina Consultants
🇨🇦Calgary, Alberta, Canada
Institut De L'Oeil Des Laurentides
🇨🇦Boisbriand, Quebec, Canada
Chi De Creteil; Ophtalmologie
🇫🇷Creteil, France
Clinique de la Louviere - Nord retine; Maladie et chirurgie des Yeux
🇫🇷Lille, France
Centre ophtalmologique Rabelais; Ophtalmologie
🇫🇷Lyon, France
Centre Paradis Monticelli; Ophtalmologie
🇫🇷Marseille, France
Hopital Lariboisiere; Ophtalmologie
🇫🇷Paris, France
CHU Poitiers - CHR La Miletrie; Ophtalmologie
🇫🇷Poitiers, France
Fondation Rothschild; Ophtalmologie
🇫🇷Paris Cedex 19, France
CHNO des Quinze Vingts; Ophtalmologie
🇫🇷Paris, France
Centres Ophtalmologique St Exupéry; Ophtalmologie
🇫🇷St Cyr Sur Loire, France
Cabinet La Maison Rouge; Ophtalmologie
🇫🇷Strasbourg, France
Universitatsklinikum Leipzig
🇩🇪Leipzig, Germany
Klinikum rechts der Isar der TU München; Augenklinik
🇩🇪München, Germany
European Interbalkan Medical Center; Ophthalmology Dpt
🇬🇷Thessaloniki, Greece
University General Hospital of Heraklion; Department of Ophthalmology
🇬🇷Heraklion, Greece
Universitätsklinikum Tübingen
🇩🇪Tuebingen, Germany
Bajcsy-Zsilinszky Hospital
🇭🇺Budapest, Hungary
Kenezy Gyula Korhaz; Szemeszet
🇭🇺Debrecen, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
🇭🇺Budapest, Hungary
Soroka university medical center; Ophtalmology
🇮🇱Beer Sheva, Israel
Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET
🇭🇺Szombathely, Hungary
Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
Rambam Health Care Campus
🇮🇱Haifa, Israel
Hadassah MC; Ophtalmology
🇮🇱Jerusalem, Israel
Rabin Medical Center
🇮🇱Petach Tikva, Israel
Meir Medical Center; Ophtalmology
🇮🇱Kfar Saba, Israel
Kaplan Medical Center; Ophtalmology
🇮🇱Rehovot, Israel
Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche
🇮🇹Napoli, Campania, Italy
Tel Aviv Sourasky MC; Ophtalmology
🇮🇱Tel Aviv, Israel
ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
🇮🇹Milano, Lombardia, Italy
Università degli Studi dell'Insubria; Clinica Oculistica
🇮🇹Varese, Lombardia, Italy
Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica
🇮🇹Firenze, Toscana, Italy
Ospedale Classificato Equiparato Sacro Cuore - Don Calabria; Dipartimento Oculistica
🇮🇹Negrar - Verona, Veneto, Italy
Hospital Universitario Virgen de la Macarena; Servicio de Oftalmologia
🇪🇸Sevilla, Spain
Institut de la Macula i la retina
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oftalmologia
🇪🇸Barcelona, Spain
Clinica Doctores Piñero; Oftalmologia
🇪🇸Sevilla, Spain
Hospital Clinico Universitario de Valladolid; Servicio de oftalmologia
🇪🇸Valladolid, Spain
Kent & Canterbury Hospital
🇬🇧Canterbury, United Kingdom
Hull and East Yorkshire Eye Hospital
🇬🇧Hull, United Kingdom
Hospital Universitario Rio Hortega; Servicio de Oftalmologia
🇪🇸Valladolid, Spain
Bristol Eye Hospital
🇬🇧Bristol, United Kingdom
John Radcliffe Hospital; Oxford Eye Hospital
🇬🇧Oxford, United Kingdom
University Hospital Southampton NHS Foundation Trust
🇬🇧Southhampton, United Kingdom
Pinderfields Hospital; Clinical Research Team, Rowan House
🇬🇧Wakefield, United Kingdom
Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria
🇮🇹Pisa, Toscana, Italy
Sunderland Eye Infirmary
🇬🇧Sunderland, United Kingdom
Duke University Eye Center; Vitreoretinal
🇺🇸Durham, North Carolina, United States
Retina Consultants of Houston
🇺🇸Houston, Texas, United States
Med Center Ophthalmology Assoc
🇺🇸San Antonio, Texas, United States
Botelho Hospital da Visao
🇧🇷Blumenau, SC, Brazil
Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
🇦🇹Wien, Austria
Pomorski Uniwersytet Medyczny w Szczecinie, Zaklad Patologii Ogolnej PUM"
🇵🇱Szczecin, Poland