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

October 20, 2023 updated by: Gyroscope Therapeutics Limited

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

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

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

83

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • East Melbourne, Australia, 3002
        • The University of Melbourne - The Centre for Eye Research Australia (CERA)
      • Nedlands, Australia, 6009
        • Lions Eye Institute (LEI) - Nedlands
  • France
      • Bordeaux, France, 33000
        • Centre Ophtalmologique Retine Gallien
      • Créteil, France, 94000
        • Centre Hospitalier Intercommunal Creteil
      • Dijon, France, 2100
        • CHU Dijon - Hopital Mitterrand
      • Lyon, France, 69004
        • Hopital de la Croix Rousse - GH Nord
      • Marseille, France, 13008
        • Centre Paradis Monticelli
      • Nantes, France, 44093
        • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
      • Paris, France, 75010
        • Hopital Lariboisiere
      • Poitiers, France, 86021
        • Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital
  • Germany
      • Freiburg, Germany, 79106
        • EyeNet Baden-Wuerttemberg
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf
      • Lübeck, Germany, 23538
        • University Hospital Schleswig-Holstein - Campus Luebeck
      • Munich, Germany, 81675
        • Klinikum Rechts der isar Der Technische Universitaet Muenchen
      • Münster, Germany, 48145
        • St. Franziskus-Hospital
      • Siegburg, Germany, 53721
        • MVZ ADTC Siegburg GmbH
      • Sulzbach, Germany, 66280
        • Augenklinik Sulzbach
      • Tübingen, Germany, 72076
        • Universitaetsklinikum Tuebingen
  • Netherlands
      • Amsterdam, Netherlands, 1105
        • Amsterdam UMC - Locatie AMC
      • Nijmegen, Netherlands, 6525
        • Radboud Universitair Medisch Centrum
  • Poland
      • Bydgoszcz, Poland, 85-316
        • Specjalistyczny Osrodek Okulistyczny Oculomedica
      • Bydgoszcz, Poland, 85-631
        • Oftalmika - Prywatna Klinika Okulistyczna
      • Tarnowskie Góry, Poland, 42-600
        • Caminomed
    • Rojna
      • Łódź, Rojna, Poland, 91-134
        • Okulistyczna "Jasne Blonia" Sp. z o.o.
  • Spain
      • Barcelona, Spain, 08035
        • Instituto de Microcirugia Ocular
      • Barcelona, Spain, 08915
        • Hospital General de Catalunya Sant Cugat del Valles
      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos
      • Madrid, Spain, 28035
        • VISSUM Mirasierra
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra - Pamplona
  • United Kingdom
      • Burnley, United Kingdom, BB10 2PQ
        • Burnley General Hospital
      • Glasgow, United Kingdom, G12 0YN
        • NHS Greater Glasgow and Clyde
      • Leeds, United Kingdom, LS9 7TF
        • Leeds Teaching Hospitals NHS Trust
      • London, United Kingdom, W1G 7LB
        • Retina Clinic London
      • Manchester, United Kingdom, M13 9WL
        • Manchester Royal Eye Hospital
      • Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
      • Salisbury, United Kingdom, SP2 8BJ
        • Salisbury NHS Foundation Trust
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Sunderland, United Kingdom, SR2 9HP
        • Sunderland Eye Infirmary
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Retinal Research Institute (retina consultants of AZ)
      • Tucson, Arizona, United States, 85704
        • Retina Centers PC
    • California
      • Beverly Hills, California, United States, 90211
        • Retina Vitreous Associates Medical Group
      • Palo Alto, California, United States, 94303
        • Byers Eye Institute at Stanford
    • Florida
      • Fort Myers, Florida, United States, 33907
        • Retina Health Center
      • Saint Petersburg, Florida, United States, 33711
        • Retina Vitreous Associates of Florida
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center
      • Marietta, Georgia, United States, 30060
        • Georgia Retina PC
    • Illinois
      • Lemont, Illinois, United States, 60452
        • University Retina Macula Associates PC
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Midwest Eye Institute Northside
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Wolfe Eye Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University School of Medicine
      • Baltimore, Maryland, United States, 21209
        • The Retina Care Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalamic Consultants of Boston (OCB)
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Pepose Vision Institute
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New Jersey
      • Vauxhall, New Jersey, United States, 07088
        • New Jersey Retina Research Foundation
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Vitreoretinal Consultants
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • Rochester, New York, United States, 14620
        • Retina Association of Western New York
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Medical Center - Wake Forest University School of Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Eye Institute
    • Oregon
      • Portland, Oregon, United States, 97239
        • Casey Eye Institute - OHSU
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Mid-Atlantic Retina
    • Texas
      • Bellaire, Texas, United States, 77401
        • Retina Consultants of Houston-TMC
      • Dallas, Texas, United States, 75231
        • Retina Foundation of the Southwest
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Houston
      • Willow Park, Texas, United States, 76087
        • Strategic Clinical Research LLC
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Retina Associates of Utah
    • Washington
      • Bellevue, Washington, United States, 98004
        • Proliance Retina (formally known as Vitreoretinal Associates of Washington)
      • Silverdale, Washington, United States, 98383
        • Retina Center Northwest
      • Spokane, Washington, United States, 99204
        • Spokane Eye Clinical Research
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Secondary care.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geographic Atrophy (GA)
Time Frame: Up to 96 weeks
Change from baseline in area of Geographic Atrophy, as assessed by Fundus Auto Fluoresence measured in mm2
Up to 96 weeks
Colour Fundus (CF)
Time Frame: Up to 96 weeks
Change from baseline in Colour Fundus Photography measured in mm2
Up to 96 weeks
Retinal Drusen Volume
Time Frame: Up to 96 weeks
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)
Time Frame: Up to 96 weeks
Change from baseline in ETDRS BCVA reading score
Up to 96 weeks
Retinal sensitivity
Time Frame: Up to 96 weeks
Change from baseline in retinal sensitivity as assessed by microperimetry
Up to 96 weeks
Visual Functioning Questionnaire
Time Frame: 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
Up to 96 weeks
Medical Events of Interest (MEI)
Time Frame: Up to 96 weeks
Change from baseline in percentage of Participants with MEI
Up to 96 weeks
Monocular and Binocular Reading Performance
Time Frame: Up to 96 weeks
Change in Monocular and Binocular Reading Performance measured in words/min
Up to 96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gyroscope Therapeutics Limited

Collaborators

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2019

Primary Completion (Estimated)

March 2, 2024

Study Completion (Estimated)

March 2, 2024

Study Registration Dates

First Submitted

March 22, 2019

First Submitted That Met QC Criteria

March 27, 2019

First Posted (Actual)

March 28, 2019

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTSCOPE
  • CPPY988A12001 (Other Identifier: Novartis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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