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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03894020
Recruitment Status : Active, not recruiting
First Posted : March 28, 2019
Last Update Posted : October 23, 2023
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Gyroscope Therapeutics Limited

Study Description
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Brief Summary:
An observational study to evaluate the natural progression of dry AMD in genetically defined subjects

Condition or disease
Dry Age-related Macular Degeneration Macular Degeneration Retinal Disease Retinal Degeneration Geographic Atrophy Macular Atrophy

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 Design
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Study Type : Observational
Actual Enrollment : 83 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Study of Disease Progression in Genetically Defined Subjects With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : March 2, 2024
Estimated Study Completion Date : March 2, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Colour Fundus (CF) [ Time Frame: Up to 96 weeks ]
    Change from baseline in Colour Fundus Photography measured in mm2

  3. Retinal Drusen Volume [ Time Frame: Up to 96 weeks ]
    Change from baseline in retinal drusen volume measured in mm3

  4. 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

  5. Retinal sensitivity [ Time Frame: Up to 96 weeks ]
    Change from baseline in retinal sensitivity as assessed by microperimetry

  6. 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

  7. Medical Events of Interest (MEI) [ Time Frame: Up to 96 weeks ]
    Change from baseline in percentage of Participants with MEI

  8. Monocular and Binocular Reading Performance [ Time Frame: Up to 96 weeks ]
    Change in Monocular and Binocular Reading Performance measured in words/min


Biospecimen Retention:   Samples With DNA
Saliva Samples, blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Secondary care.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894020


Locations
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Sponsors and Collaborators
Gyroscope Therapeutics Limited
Novartis Pharmaceuticals
More Information
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Responsible Party: Gyroscope Therapeutics Limited
ClinicalTrials.gov Identifier: NCT03894020    
Other Study ID Numbers: GTSCOPE
CPPY988A12001 ( Other Identifier: Novartis )
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: October 23, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Retinal Diseases
Retinal Degeneration
Anetoderma
Atrophy
 Eye Diseases
Pathological Conditions, Anatomical
Eye Diseases, Hereditary
Connective Tissue Diseases
Skin Abnormalities
Skin Diseases