CClinicalTrials.gg
TerminatedNCT03894020Updated Oct 30, 2024

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

An observational study in Dry Age-related Macular Degeneration, Macular Degeneration and Retinal Disease, sponsored by Gyroscope Therapeutics Limited. Terminated at 71 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-30.

Sponsored by Gyroscope Therapeutics Limited · Observational

Why this study was terminated
The study was terminated due to the interim analysis demonstrating lack of treatment efficacy.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
83
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Dry Age-related Macular Degeneration
  • Macular Degeneration
  • Retinal Disease
  • Retinal Degeneration
  • Geographic Atrophy
  • Macular Atrophy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Secondary care.

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

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
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
83 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
05

What researchers measure

Primary outcomes

  1. Geographic Atrophy (GA)

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

    Time frame: Up to 96 weeks

  2. Colour Fundus (CF)

    Change from baseline in Colour Fundus Photography measured in mm2

    Time frame: Up to 96 weeks

  3. Retinal Drusen Volume

    Change from baseline in retinal drusen volume measured in mm3

    Time frame: Up to 96 weeks

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

    Change from baseline in ETDRS BCVA reading score

    Time frame: Up to 96 weeks

  5. Retinal sensitivity

    Change from baseline in retinal sensitivity as assessed by microperimetry

    Time frame: Up to 96 weeks

  6. 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

    Time frame: Up to 96 weeks

  7. Medical Events of Interest (MEI)

    Change from baseline in percentage of Participants with MEI

    Time frame: Up to 96 weeks

  8. Monocular and Binocular Reading Performance

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

    Time frame: Up to 96 weeks

06

Study locations

71 sites
  • Retinal Research Institute (retina consultants of AZ)
    Phoenix, Arizona 85053, United States
  • Retina Centers PC
    Tucson, Arizona 85704, United States
  • Retina Vitreous Associates Medical Group
    Beverly Hills, California 90211, United States
  • Byers Eye Institute at Stanford
    Palo Alto, California 94303, United States
  • Retina Health Center
    Fort Myers, Florida 33907, United States
  • Retina Vitreous Associates of Florida
    Saint Petersburg, Florida 33711, United States
  • Southeast Retina Center
    Augusta, Georgia 30909, United States
  • Georgia Retina PC
    Marietta, Georgia 30060, United States
  • University Retina Macula Associates PC
    Lemont, Illinois 60452, United States
  • Midwest Eye Institute Northside
    Indianapolis, Indiana 46290, United States
  • Wolfe Eye Clinic
    West Des Moines, Iowa 50266, United States
  • The Retina Care Center
    Baltimore, Maryland 21209, United States
  • Johns Hopkins University School of Medicine
    Baltimore, Maryland 21287, United States
  • Ophthalamic Consultants of Boston (OCB)
    Boston, Massachusetts 02114, United States
  • Pepose Vision Institute
    Chesterfield, Missouri 63017, United States
  • Sierra Eye Associates
    Reno, Nevada 89502, United States
  • New Jersey Retina Research Foundation
    Vauxhall, New Jersey 07088, United States
  • Long Island Vitreoretinal Consultants
    Great Neck, New York 11021, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • Retina Association of Western New York
    Rochester, New York 14620, United States
  • Wake Forest Baptist Medical Center - Wake Forest University School of Medicine
    Winston-Salem, North Carolina 27157, United States
  • Cincinnati Eye Institute
    Cincinnati, Ohio 45242, United States
  • Casey Eye Institute - OHSU
    Portland, Oregon 97239, United States
  • Mid-Atlantic Retina
    Philadelphia, Pennsylvania 19107, United States
  • Retina Consultants of Houston-TMC
    Bellaire, Texas 77401, United States
  • Retina Foundation of the Southwest
    Dallas, Texas 75231, United States
  • Retina Consultants of Houston
    The Woodlands, Texas 77384, United States
  • Strategic Clinical Research LLC
    Willow Park, Texas 76087, United States
  • Retina Associates of Utah
    Salt Lake City, Utah 84107, United States
  • Proliance Retina (formally known as Vitreoretinal Associates of Washington)
    Bellevue, Washington 98004, United States
  • Retina Center Northwest
    Silverdale, Washington 98383, United States
  • Spokane Eye Clinical Research
    Spokane, Washington 99204, United States
  • West Virginia University
    Morgantown, West Virginia 26506, United States
  • The University of Melbourne - The Centre for Eye Research Australia (CERA)
    East Melbourne, 3002, Australia
  • Lions Eye Institute (LEI) - Nedlands
    Nedlands, 6009, Australia
  • Centre Ophtalmologique Retine Gallien
    Bordeaux, 33000, France
  • Centre Hospitalier Intercommunal Creteil
    Créteil, 94000, France
  • CHU Dijon - Hôpital Mitterrand
    Dijon, 2100, France
  • Hopital de la Croix Rousse - GH Nord
    Lyon, 69004, France
  • Centre Paradis Monticelli
    Marseille, 13008, France
  • Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu
    Nantes, 44093, France
  • Hopital Lariboisiere
    Paris, 75010, France
  • Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital
    Poitiers, 86021, France
  • EyeNet Baden-Wuerttemberg
    Freiburg, 79106, Germany
  • Universitaetsklinikum Hamburg-Eppendorf
    Hamburg, 20246, Germany
  • University Hospital Schleswig-Holstein - Campus Luebeck
    Lübeck, 23538, Germany
  • Klinikum rechts der Isar der Technische Universitaet Muenchen
    Munich, 81675, Germany
  • St. Franziskus-Hospital
    Münster, 48145, Germany
  • MVZ ADTC Siegburg GmbH
    Siegburg, 53721, Germany
  • Augenklinik Sulzbach
    Sulzbach, 66280, Germany
  • Universitaetsklinikum Tuebingen
    Tübingen, 72076, Germany
  • Amsterdam UMC - Locatie AMC
    Amsterdam, 1105, Netherlands
  • Radboud Universitair Medisch Centrum
    Nijmegen, 6525, Netherlands
  • Okulistyczna "Jasne Blonia" Sp. z o.o.
    Łódź, Rojna 91-134, Poland
  • Specjalistyczny Osrodek Okulistyczny Oculomedica
    Bydgoszcz, 85-316, Poland
  • Oftalmika - Prywatna Klinika Okulistyczna
    Bydgoszcz, 85-631, Poland
  • Caminomed
    Tarnowskie Góry, 42-600, Poland
  • Instituto de microcirugía ocular
    Barcelona, 08035, Spain
  • Hospital General de Catalunya Sant Cugat del Valles
    Barcelona, 08915, Spain
  • VISSUM Mirasierra
    Madrid, 28035, Spain
  • Hospital Clinico San Carlos
    Madrid, 28040, Spain
  • Clinica Universidad de Navarra - Pamplona
    Pamplona, 31008, Spain
  • Burnley General Hospital
    Burnley, BB10 2PQ, United Kingdom
  • NHS Greater Glasgow and Clyde
    Glasgow, G12 0YN, United Kingdom
  • Leeds Teaching Hospitals NHS Trust
    Leeds, LS9 7TF, United Kingdom
  • Retina Clinic London
    London, W1G 7LB, United Kingdom
  • Manchester Royal Eye Hospital
    Manchester, M13 9WL, United Kingdom
  • John Radcliffe Hospital
    Oxford, OX3 9DU, United Kingdom
  • Salisbury NHS Foundation Trust
    Salisbury, SP2 8BJ, United Kingdom
  • Southampton General Hospital
    Southampton, SO16 6YD, United Kingdom
  • Sunderland Eye Infirmary
    Sunderland, SR2 9HP, United Kingdom
07

Registry details

Key details

Study ID
NCT03894020
Lead sponsor
Gyroscope Therapeutics Limited
Collaborators
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Mar 28, 2019
Start date
Jan 8, 2019
Primary completion
Mar 25, 2024
Completion
Mar 25, 2024
Last update
Oct 30, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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