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Dry Age-related Macular DegenerationNCT03894020

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

An observational study of Dry Age-related Macular Degeneration and Macular Degeneration, run by Gyroscope Therapeutics Limited at 71 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

An observational study to evaluate the natural progression of dry AMD in genetically defined subjects Read more about this study

Who is it for?
Ages 18 years and older
How many people
83 participants
Where
71 sitesin 8 countries
Study dates
8 Jan 2019to 25 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Secondary care.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

71 sites in 8 countries.

71 sites in 8 countries

United States33 sites

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • The Retina Care Center

    Baltimore, Maryland, 21209

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287

  • Retina Consultants of Houston-TMC

    Bellaire, Texas, 77401

  • Proliance Retina (formally known as Vitreoretinal Associates of Washington)

    Bellevue, Washington, 98004

  • Retina Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Ophthalamic Consultants of Boston (OCB)

    Boston, Massachusetts, 02114

  • Pepose Vision Institute

    Chesterfield, Missouri, 63017

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242

  • Retina Foundation of the Southwest

    Dallas, Texas, 75231

  • Retina Health Center

    Fort Myers, Florida, 33907

  • Long Island Vitreoretinal Consultants

    Great Neck, New York, 11021

  • Midwest Eye Institute Northside

    Indianapolis, Indiana, 46290

  • University Retina Macula Associates PC

    Lemont, Illinois, 60452

  • Georgia Retina PC

    Marietta, Georgia, 30060

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Columbia University Medical Center

    New York, New York, 10032

  • Byers Eye Institute at Stanford

    Palo Alto, California, 94303

  • Mid-Atlantic Retina

    Philadelphia, Pennsylvania, 19107

  • Retinal Research Institute (retina consultants of AZ)

    Phoenix, Arizona, 85053

  • Casey Eye Institute - OHSU

    Portland, Oregon, 97239

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retina Association of Western New York

    Rochester, New York, 14620

  • Retina Associates of Utah

    Salt Lake City, Utah, 84107

  • Retina Center Northwest

    Silverdale, Washington, 98383

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida, 33711

  • Retina Consultants of Houston

    The Woodlands, Texas, 77384

  • Retina Centers PC

    Tucson, Arizona, 85704

  • New Jersey Retina Research Foundation

    Vauxhall, New Jersey, 07088

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

  • Strategic Clinical Research LLC

    Willow Park, Texas, 76087

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

    Winston-Salem, North Carolina, 27157

Other trials in United States

United Kingdom9 sites

  • Burnley General Hospital

    Burnley, BB10 2PQ

  • NHS Greater Glasgow and Clyde

    Glasgow, G12 0YN

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF

  • Retina Clinic London

    London, W1G 7LB

  • Manchester Royal Eye Hospital

    Manchester, M13 9WL

  • John Radcliffe Hospital

    Oxford, OX3 9DU

  • Salisbury NHS Foundation Trust

    Salisbury, SP2 8BJ

  • Southampton General Hospital

    Southampton, SO16 6YD

  • Sunderland Eye Infirmary

    Sunderland, SR2 9HP

Other trials in United Kingdom

France8 sites

  • Centre Ophtalmologique Retine Gallien

    Bordeaux, 33000

  • Centre Hospitalier Intercommunal Creteil

    Créteil, 94000

  • CHU Dijon - Hôpital Mitterrand

    Dijon, 2100

  • Hopital de la Croix Rousse - GH Nord

    Lyon, 69004

  • Centre Paradis Monticelli

    Marseille, 13008

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

    Nantes, 44093

  • Hopital Lariboisiere

    Paris, 75010

  • Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital

    Poitiers, 86021

Other trials in France

Germany8 sites

  • EyeNet Baden-Wuerttemberg

    Freiburg im Breisgau, 79106

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • University Hospital Schleswig-Holstein - Campus Luebeck

    Lübeck, 23538

  • Klinikum rechts der Isar der Technische Universitaet Muenchen

    Munich, 81675

  • St. Franziskus-Hospital

    Münster, 48145

  • MVZ ADTC Siegburg GmbH

    Siegburg, 53721

  • Augenklinik Sulzbach

    Sulzbach, 66280

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

Other trials in Germany

Spain5 sites

  • Instituto de microcirugía ocular

    Barcelona, 08035

  • Hospital General de Catalunya Sant Cugat del Valles

    Barcelona, 08915

  • VISSUM Mirasierra

    Madrid, 28035

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Clinica Universidad de Navarra - Pamplona

    Pamplona, 31008

Other trials in Spain

Poland4 sites

  • Specjalistyczny Osrodek Okulistyczny Oculomedica

    Bydgoszcz, 85-316

  • Oftalmika - Prywatna Klinika Okulistyczna

    Bydgoszcz, 85-631

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

    Lodz, Rojna, 91-134

  • Caminomed

    Tarnowskie Góry, 42-600

Other trials in Poland

Australia2 sites

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

    East Melbourne, 3002

  • Lions Eye Institute (LEI) - Nedlands

    Nedlands, 6009

Other trials in Australia

Netherlands2 sites

  • Amsterdam UMC - Locatie AMC

    Amsterdam, 1105

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525

Other trials in Netherlands

About this study

Official title: 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

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.

Medical subject headings
Macular Degeneration, Retinal Diseases, Retinal Degeneration, Geographic Atrophy, Anetoderma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Geographic Atrophy (GA)

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

    Measured: Up to 96 weeks

  2. Colour Fundus (CF)

    Change from baseline in Colour Fundus Photography measured in mm2

    Measured: Up to 96 weeks

  3. Retinal Drusen Volume

    Change from baseline in retinal drusen volume measured in mm3

    Measured: Up to 96 weeks

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

    Change from baseline in ETDRS BCVA reading score

    Measured: Up to 96 weeks

  5. Retinal sensitivity

    Change from baseline in retinal sensitivity as assessed by microperimetry

    Measured: 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

    Measured: Up to 96 weeks

  7. Medical Events of Interest (MEI)

    Change from baseline in percentage of Participants with MEI

    Measured: Up to 96 weeks

  8. Monocular and Binocular Reading Performance

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

    Measured: Up to 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2019
  2. Study start8 Jan 2019
  3. Primary completion25 Mar 2024
  4. Study completion25 Mar 2024

Why it stopped: The study was terminated due to the interim analysis demonstrating lack of treatment efficacy.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03894020
Sponsor's protocol ID
GTSCOPE
Other IDs
CPPY988A12001
Status last verified
Oct 2024
First submitted
22 Mar 2019
Last updated
30 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Dry Age-related Macular Degeneration and Macular Degeneration, run by Gyroscope Therapeutics Limited at 71 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, United Kingdom, France, Germany, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The study was terminated due to the interim analysis demonstrating lack of treatment efficacy.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geographic Atrophy (GA) (time frame: Up to 96 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03894020.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.

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