Clinical trial NCT03894020: GTSCOPE - To Evaluate the Natural Progression of Dry Age-related Macular Degeneration (AMD)
Official title: A Study of Disease Progression in Genetically Defined Subjects With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dry Age-related Macular Degeneration
Macular Degeneration
Retinal Disease
Retinal Degeneration
Geographic Atrophy
Macular Atrophy
Lead sponsor: Gyroscope Therapeutics Limited
Sponsor class: INDUSTRY
Collaborators: name: Novartis Pharmaceuticals
First posted: 2019-03-28
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Secondary care.

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.

Eligibility criteria: Inclusion Criteria:

1. Adults with unilateral or bilateral Geographic Atrophy (GA) due to Age-related Macular Degeneration (AMD)
2. BCVA of 40 letters or better using ETDRS charts

Exclusion Criteria:

1. Evidence or history of neovascular Age-related Macular Degeneration (AMD) or diabetic retinopathy
2. Significant ocular or non-ocular disease that would impact the subject's ability to participate in the study
3. 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

Primary outcomes:
measure: Geographic Atrophy (GA)
timeFrame: Up to 96 weeks
measure: Colour Fundus (CF)
timeFrame: Up to 96 weeks
measure: Retinal Drusen Volume
timeFrame: Up to 96 weeks
measure: Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)
timeFrame: Up to 96 weeks
measure: Retinal sensitivity
timeFrame: Up to 96 weeks
measure: Visual Functioning Questionnaire
timeFrame: Up to 96 weeks
measure: Medical Events of Interest (MEI)
timeFrame: Up to 96 weeks
measure: Monocular and Binocular Reading Performance
timeFrame: Up to 96 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Research Institute (retina consultants of AZ)
state: Arizona
city: Tucson
country: United States
facility: Retina Centers PC
state: Arizona
city: Beverly Hills
country: United States
facility: Retina Vitreous Associates Medical Group
state: California
city: Palo Alto
country: United States
facility: Byers Eye Institute at Stanford
state: California
city: Fort Myers
country: United States
facility: Retina Health Center
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Marietta
country: United States
facility: Georgia Retina PC
state: Georgia
city: Lemont
country: United States
facility: University Retina Macula Associates PC
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Eye Institute Northside
state: Indiana
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Baltimore
country: United States
facility: The Retina Care Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: Ophthalamic Consultants of Boston (OCB)
state: Massachusetts
city: Chesterfield
country: United States
facility: Pepose Vision Institute
state: Missouri
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Vauxhall
country: United States
facility: New Jersey Retina Research Foundation
state: New Jersey
city: Great Neck
country: United States
facility: Long Island Vitreoretinal Consultants
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: Retina Association of Western New York
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center - Wake Forest University School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Portland
country: United States
facility: Casey Eye Institute - OHSU
state: Oregon
city: Philadelphia
country: United States
facility: Mid-Atlantic Retina
state: Pennsylvania
city: Bellaire
country: United States
facility: Retina Consultants of Houston-TMC
state: Texas
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research LLC
state: Texas
city: Salt Lake City
country: United States
facility: Retina Associates of Utah
state: Utah
city: Bellevue
country: United States
facility: Proliance Retina (formally known as Vitreoretinal Associates of Washington)
state: Washington
city: Silverdale
country: United States
facility: Retina Center Northwest
state: Washington
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: East Melbourne
country: Australia
facility: The University of Melbourne - The Centre for Eye Research Australia (CERA)
city: Nedlands
country: Australia
facility: Lions Eye Institute (LEI) - Nedlands
city: Bordeaux
country: France
facility: Centre Ophtalmologique Retine Gallien
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal Creteil
city: Dijon
country: France
facility: CHU Dijon - Hôpital Mitterrand
city: Lyon
country: France
facility: Hopital de la Croix Rousse - GH Nord
city: Marseille
country: France
facility: Centre Paradis Monticelli
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
city: Paris
country: France
facility: Hopital Lariboisiere
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital
city: Freiburg
country: Germany
facility: EyeNet Baden-Wuerttemberg
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Lübeck
country: Germany
facility: University Hospital Schleswig-Holstein - Campus Luebeck
city: Munich
country: Germany
facility: Klinikum rechts der Isar der Technische Universitaet Muenchen
city: Münster
country: Germany
facility: St. Franziskus-Hospital
city: Siegburg
country: Germany
facility: MVZ ADTC Siegburg GmbH
city: Sulzbach
country: Germany
facility: Augenklinik Sulzbach
city: Tübingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC - Locatie AMC
city: Nijmegen
country: Netherlands
facility: Radboud Universitair Medisch Centrum
city: Łódź
country: Poland
facility: Okulistyczna "Jasne Blonia" Sp. z o.o.
state: Rojna
city: Bydgoszcz
country: Poland
facility: Specjalistyczny Osrodek Okulistyczny Oculomedica
city: Bydgoszcz
country: Poland
facility: Oftalmika - Prywatna Klinika Okulistyczna
city: Tarnowskie Góry
country: Poland
facility: Caminomed
city: Barcelona
country: Spain
facility: Instituto de microcirugía ocular
city: Barcelona
country: Spain
facility: Hospital General de Catalunya Sant Cugat del Valles
city: Madrid
country: Spain
facility: VISSUM Mirasierra
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra - Pamplona
city: Burnley
country: United Kingdom
facility: Burnley General Hospital
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: London
country: United Kingdom
facility: Retina Clinic London
city: Manchester
country: United Kingdom
facility: Manchester Royal Eye Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Salisbury
country: United Kingdom
facility: Salisbury NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Sunderland
country: United Kingdom
facility: Sunderland Eye Infirmary
Study officials:
References: