GTSCOPE - To Evaluate the Natural Progression of Dry Age-related Macular Degeneration (AMD)

Macular Degeneration Clinical Trial

Official title:

A Study of Disease Progression in Genetically Defined Subjects With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03894020
• Other study ID #: GTSCOPE
• Secondary ID: CPPY988A12001
• Status: Active, not recruiting
• Start date: January 8, 2019
• Est. completion date: March 2, 2024

Study information

• Verified date: October 2023
• Source: Gyroscope Therapeutics Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An observational study to evaluate the natural progression of dry AMD in genetically defined subjects

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 83
• Est. completion date: March 2, 2024
• Est. primary completion date: March 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Dry Age-related Macular Degeneration
• Geographic Atrophy
• Macular Atrophy
• Macular Degeneration
• Retinal Degeneration
• Retinal Disease
• Retinal Diseases

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Gyroscope Therapeutics Limited	Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geographic Atrophy (GA)	Change from baseline in area of Geographic Atrophy, as assessed by Fundus Auto Fluoresence measured in mm2	Up to 96 weeks
Primary	Colour Fundus (CF)	Change from baseline in Colour Fundus Photography measured in mm2	Up to 96 weeks
Primary	Retinal Drusen Volume	Change from baseline in retinal drusen volume measured in mm3	Up to 96 weeks
Primary	Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)	Change from baseline in ETDRS BCVA reading score	Up to 96 weeks
Primary	Retinal sensitivity	Change from baseline in retinal sensitivity as assessed by microperimetry	Up to 96 weeks
Primary	Visual Functioning Questionnaire	Change from baseline in National Eye Institute Visual Functioning Questionnaire 25-Items Version (NEI VFQ-25) Minimum Score (Best) = 29. Maximum score (Worst) = 149	Up to 96 weeks
Primary	Medical Events of Interest (MEI)	Change from baseline in percentage of Participants with MEI	Up to 96 weeks
Primary	Monocular and Binocular Reading Performance	Change in Monocular and Binocular Reading Performance measured in words/min	Up to 96 weeks