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

NCT03894020 | Terminated

• 2 other identifiers: GTSCOPECPPY988A12001
• Study Type: observational
• Target: 83
• Locations: 8 countries
• Sites: 71

Brief Summary

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

Conditions

Dry Age-related Macular Degeneration; Macular Degeneration; Retinal Disease; Retinal Degeneration; Geographic Atrophy; Macular Atrophy

Outcome Measures

Primary Outcomes (8)

• Geographic Atrophy (GA)

  Change from baseline in area of Geographic Atrophy, as assessed by Fundus Auto Fluoresence measured in mm2

  Up to 96 weeks

• Colour Fundus (CF)

  Change from baseline in Colour Fundus Photography measured in mm2

  Up to 96 weeks

• Retinal Drusen Volume

  Change from baseline in retinal drusen volume measured in mm3

  Up to 96 weeks

• Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)

  Change from baseline in ETDRS BCVA reading score

  Up to 96 weeks

• Retinal sensitivity

  Change from baseline in retinal sensitivity as assessed by microperimetry

  Up to 96 weeks

• 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

• Medical Events of Interest (MEI)

  Change from baseline in percentage of Participants with MEI

  Up to 96 weeks

• Monocular and Binocular Reading Performance

  Change in Monocular and Binocular Reading Performance measured in words/min

  Up to 96 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Secondary care.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gyroscope Therapeutics Limited: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (71)

Retinal Research Institute (retina consultants of AZ)

Phoenix, Arizona, 85053, United States

Location

Retina Centers PC

Tucson, Arizona, 85704, United States

Location

Retina Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

Location

Retina Health Center

Fort Myers, Florida, 33907, United States

Location

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711, United States

Location

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

Georgia Retina PC

Marietta, Georgia, 30060, United States

Location

University Retina Macula Associates PC

Lemont, Illinois, 60452, United States

Location

Midwest Eye Institute Northside

Indianapolis, Indiana, 46290, United States

Location

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

Location

The Retina Care Center

Baltimore, Maryland, 21209, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Ophthalamic Consultants of Boston (OCB)

Boston, Massachusetts, 02114, United States

Location

Pepose Vision Institute

Chesterfield, Missouri, 63017, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

New Jersey Retina Research Foundation

Vauxhall, New Jersey, 07088, United States

Location

Long Island Vitreoretinal Consultants

Great Neck, New York, 11021, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Retina Association of Western New York

Rochester, New York, 14620, United States

Location

Wake Forest Baptist Medical Center - Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

Casey Eye Institute - OHSU

Portland, Oregon, 97239, United States

Location

Mid-Atlantic Retina

Philadelphia, Pennsylvania, 19107, United States

Location

Retina Consultants of Houston-TMC

Bellaire, Texas, 77401, United States

Location

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

Location

Retina Consultants of Houston

The Woodlands, Texas, 77384, United States

Location

Strategic Clinical Research LLC

Willow Park, Texas, 76087, United States

Location

Retina Associates of Utah

Salt Lake City, Utah, 84107, United States

Location

Proliance Retina (formally known as Vitreoretinal Associates of Washington)

Bellevue, Washington, 98004, United States

Location

Retina Center Northwest

Silverdale, Washington, 98383, United States

Location

Spokane Eye Clinical Research

Spokane, Washington, 99204, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

The University of Melbourne - The Centre for Eye Research Australia (CERA)

East Melbourne, 3002, Australia

Location

Lions Eye Institute (LEI) - Nedlands

Nedlands, 6009, Australia

Location

Centre Ophtalmologique Retine Gallien

Bordeaux, 33000, France

Location

Centre Hospitalier Intercommunal Creteil

Créteil, 94000, France

Location

CHU Dijon - Hôpital Mitterrand

Dijon, 2100, France

Location

Hopital de la Croix Rousse - GH Nord

Lyon, 69004, France

Location

Centre Paradis Monticelli

Marseille, 13008, France

Location

Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu

Nantes, 44093, France

Location

Hopital Lariboisiere

Paris, 75010, France

Location

Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital

Poitiers, 86021, France

Location

EyeNet Baden-Wuerttemberg

Freiburg im Breisgau, 79106, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

University Hospital Schleswig-Holstein - Campus Luebeck

Lübeck, 23538, Germany

Location

Klinikum rechts der Isar der Technische Universitaet Muenchen

Munich, 81675, Germany

Location

St. Franziskus-Hospital

Münster, 48145, Germany

Location

MVZ ADTC Siegburg GmbH

Siegburg, 53721, Germany

Location

Augenklinik Sulzbach

Sulzbach, 66280, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany

Location

Amsterdam UMC - Locatie AMC

Amsterdam, 1105, Netherlands

Location

Radboud Universitair Medisch Centrum

Nijmegen, 6525, Netherlands

Location

Okulistyczna "Jasne Blonia" Sp. z o.o.

Lodz, Rojna, 91-134, Poland

Location

Specjalistyczny Osrodek Okulistyczny Oculomedica

Bydgoszcz, 85-316, Poland

Location

Oftalmika - Prywatna Klinika Okulistyczna

Bydgoszcz, 85-631, Poland

Location

Caminomed

Tarnowskie Góry, 42-600, Poland

Location

Instituto de microcirugía ocular

Barcelona, 08035, Spain

Location

Hospital General de Catalunya Sant Cugat del Valles

Barcelona, 08915, Spain

Location

VISSUM Mirasierra

Madrid, 28035, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Clinica Universidad de Navarra - Pamplona

Pamplona, 31008, Spain

Location

Burnley General Hospital

Burnley, BB10 2PQ, United Kingdom

Location

NHS Greater Glasgow and Clyde

Glasgow, G12 0YN, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

Retina Clinic London

London, W1G 7LB, United Kingdom

Location

Manchester Royal Eye Hospital

Manchester, M13 9WL, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Salisbury NHS Foundation Trust

Salisbury, SP2 8BJ, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Sunderland Eye Infirmary

Sunderland, SR2 9HP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva Samples, blood samples

MeSH Terms

Conditions

Macular Degeneration; Retinal Diseases; Retinal Degeneration; Geographic Atrophy; Anetoderma

Condition Hierarchy (Ancestors)

Eye Diseases; Eye Diseases, Hereditary; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Abnormalities; Skin Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: March 28, 2019
• Study Start: January 8, 2019
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

NL (2); US (33); DE (8); PL (4); FR (8); AU (2); ES (5); GB (9)