GTSCOPE - To Evaluate the Natural Progression of Dry Age-related Macular Degeneration (AMD)
- Conditions
- Retinal DiseaseGeographic AtrophyDry Age-related Macular DegenerationMacular DegenerationMacular AtrophyRetinal Degeneration
- Registration Number
- NCT03894020
- Lead Sponsor
- Gyroscope Therapeutics Limited
- Brief Summary
An observational study to evaluate the natural progression of dry AMD in genetically defined subjects
- Detailed Description
Prospective, observational study to evaluate the natural progression of anatomical and functional visual parameters in genetically defined subjects with GA due to AMD.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 83
- Adults with unilateral or bilateral Geographic Atrophy (GA) due to Age-related Macular Degeneration (AMD)
- BCVA of 40 letters or better using ETDRS charts
- Evidence or history of neovascular Age-related Macular Degeneration (AMD) or diabetic retinopathy
- Significant ocular or non-ocular disease that would impact the subject's ability to participate in the study
- Participation in another research study involving an investigational product within the previous 4 weeks or 5 half-lives whichever is longer from the screening/baseline OR received a gene/cell therapy at any time previously
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Monocular and Binocular Reading Performance Up to 96 weeks Change in Monocular and Binocular Reading Performance measured in words/min
Geographic Atrophy (GA) Up to 96 weeks Change from baseline in area of Geographic Atrophy, as assessed by Fundus Auto Fluoresence measured in mm2
Colour Fundus (CF) Up to 96 weeks Change from baseline in Colour Fundus Photography measured in mm2
Retinal sensitivity Up to 96 weeks Change from baseline in retinal sensitivity as assessed by microperimetry
Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) Up to 96 weeks Change from baseline in ETDRS BCVA reading score
Medical Events of Interest (MEI) Up to 96 weeks Change from baseline in percentage of Participants with MEI
Retinal Drusen Volume Up to 96 weeks Change from baseline in retinal drusen volume measured in mm3
Visual Functioning Questionnaire Up to 96 weeks Change from baseline in National Eye Institute Visual Functioning Questionnaire 25-Items Version (NEI VFQ-25) Minimum Score (Best) = 29. Maximum score (Worst) = 149
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (71)
Retina Consultants of Houston
๐บ๐ธThe Woodlands, Texas, United States
Ophthalamic Consultants of Boston (OCB)
๐บ๐ธBoston, Massachusetts, United States
Midwest Eye Institute Northside
๐บ๐ธIndianapolis, Indiana, United States
Cincinnati Eye Institute
๐บ๐ธCincinnati, Ohio, United States
Retina Associates of Utah
๐บ๐ธSalt Lake City, Utah, United States
Retina Foundation of the Southwest
๐บ๐ธDallas, Texas, United States
Centre Paradis Monticelli
๐ซ๐ทMarseille, France
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
๐ซ๐ทNantes, France
Klinikum rechts der Isar der Technische Universitaet Muenchen
๐ฉ๐ชMunich, Germany
Augenklinik Sulzbach
๐ฉ๐ชSulzbach, Germany
Oftalmika - Prywatna Klinika Okulistyczna
๐ต๐ฑBydgoszcz, Poland
Instituto de microcirugรญa ocular
๐ช๐ธBarcelona, Spain
West Virginia University
๐บ๐ธMorgantown, West Virginia, United States
VISSUM Mirasierra
๐ช๐ธMadrid, Spain
Southeast Retina Center
๐บ๐ธAugusta, Georgia, United States
Hospital General de Catalunya Sant Cugat del Valles
๐ช๐ธBarcelona, Spain
Johns Hopkins University School of Medicine
๐บ๐ธBaltimore, Maryland, United States
Retina Vitreous Associates of Florida
๐บ๐ธSaint Petersburg, Florida, United States
MVZ ADTC Siegburg GmbH
๐ฉ๐ชSiegburg, Germany
Amsterdam UMC - Locatie AMC
๐ณ๐ฑAmsterdam, Netherlands
Specjalistyczny Osrodek Okulistyczny Oculomedica
๐ต๐ฑBydgoszcz, Poland
Southampton General Hospital
๐ฌ๐งSouthampton, United Kingdom
Proliance Retina (formally known as Vitreoretinal Associates of Washington)
๐บ๐ธBellevue, Washington, United States
Universitaetsklinikum Hamburg-Eppendorf
๐ฉ๐ชHamburg, Germany
Retina Health Center
๐บ๐ธFort Myers, Florida, United States
Pepose Vision Institute
๐บ๐ธChesterfield, Missouri, United States
New Jersey Retina Research Foundation
๐บ๐ธVauxhall, New Jersey, United States
Columbia University Medical Center
๐บ๐ธNew York, New York, United States
Lions Eye Institute (LEI) - Nedlands
๐ฆ๐บNedlands, Australia
Universitaetsklinikum Tuebingen
๐ฉ๐ชTรผbingen, Germany
The Retina Care Center
๐บ๐ธBaltimore, Maryland, United States
Retina Consultants of Houston-TMC
๐บ๐ธBellaire, Texas, United States
Hopital de la Croix Rousse - GH Nord
๐ซ๐ทLyon, France
Hopital Lariboisiere
๐ซ๐ทParis, France
The University of Melbourne - The Centre for Eye Research Australia (CERA)
๐ฆ๐บEast Melbourne, Australia
Centre Ophtalmologique Retine Gallien
๐ซ๐ทBordeaux, France
Centre Hospitalier Intercommunal Creteil
๐ซ๐ทCrรฉteil, France
University Hospital Schleswig-Holstein - Campus Luebeck
๐ฉ๐ชLรผbeck, Germany
Radboud Universitair Medisch Centrum
๐ณ๐ฑNijmegen, Netherlands
Sunderland Eye Infirmary
๐ฌ๐งSunderland, United Kingdom
Hospital Clinico San Carlos
๐ช๐ธMadrid, Spain
Georgia Retina PC
๐บ๐ธMarietta, Georgia, United States
Retina Association of Western New York
๐บ๐ธRochester, New York, United States
Retina Vitreous Associates Medical Group
๐บ๐ธBeverly Hills, California, United States
Spokane Eye Clinical Research
๐บ๐ธSpokane, Washington, United States
University Retina Macula Associates PC
๐บ๐ธLemont, Illinois, United States
Strategic Clinical Research LLC
๐บ๐ธWillow Park, Texas, United States
CHU Dijon - Hรดpital Mitterrand
๐ซ๐ทDijon, France
Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital
๐ซ๐ทPoitiers, France
EyeNet Baden-Wuerttemberg
๐ฉ๐ชFreiburg, Germany
St. Franziskus-Hospital
๐ฉ๐ชMรผnster, Germany
Okulistyczna "Jasne Blonia" Sp. z o.o.
๐ต๐ฑลรณdลบ, Rojna, Poland
Caminomed
๐ต๐ฑTarnowskie Gรณry, Poland
Clinica Universidad de Navarra - Pamplona
๐ช๐ธPamplona, Spain
Burnley General Hospital
๐ฌ๐งBurnley, United Kingdom
Sierra Eye Associates
๐บ๐ธReno, Nevada, United States
Long Island Vitreoretinal Consultants
๐บ๐ธGreat Neck, New York, United States
Retina Centers PC
๐บ๐ธTucson, Arizona, United States
Byers Eye Institute at Stanford
๐บ๐ธPalo Alto, California, United States
Wolfe Eye Clinic
๐บ๐ธWest Des Moines, Iowa, United States
Mid-Atlantic Retina
๐บ๐ธPhiladelphia, Pennsylvania, United States
NHS Greater Glasgow and Clyde
๐ฌ๐งGlasgow, United Kingdom
Manchester Royal Eye Hospital
๐ฌ๐งManchester, United Kingdom
John Radcliffe Hospital
๐ฌ๐งOxford, United Kingdom
Salisbury NHS Foundation Trust
๐ฌ๐งSalisbury, United Kingdom
Leeds Teaching Hospitals NHS Trust
๐ฌ๐งLeeds, United Kingdom
Retina Clinic London
๐ฌ๐งLondon, United Kingdom
Retinal Research Institute (retina consultants of AZ)
๐บ๐ธPhoenix, Arizona, United States
Casey Eye Institute - OHSU
๐บ๐ธPortland, Oregon, United States
Wake Forest Baptist Medical Center - Wake Forest University School of Medicine
๐บ๐ธWinston-Salem, North Carolina, United States
Retina Center Northwest
๐บ๐ธSilverdale, Washington, United States