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

Terminated

• Conditions: Retinal Disease; Geographic Atrophy; Dry Age-related Macular Degeneration; Macular Degeneration; Macular Atrophy; Retinal Degeneration

• Registration Number: NCT03894020
• Lead Sponsor: Gyroscope Therapeutics Limited

Brief Summary

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

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 Timeline

• Study Start: 2019-01-08
• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-03-27
• Study First Posted: 2019-03-28
• Primary Completion: 2024-03-25
• Study Completion: 2024-03-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Colour Fundus (CF)	Up to 96 weeks	Change from baseline in Colour Fundus Photography measured in mm2
Retinal sensitivity	Up to 96 weeks	Change from baseline in retinal sensitivity as assessed by microperimetry
Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)	Up to 96 weeks	Change from baseline in ETDRS BCVA reading score
Medical Events of Interest (MEI)	Up to 96 weeks	Change from baseline in percentage of Participants with MEI
Retinal Drusen Volume	Up to 96 weeks	Change from baseline in retinal drusen volume measured in mm3
Visual Functioning Questionnaire	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
Monocular and Binocular Reading Performance	Up to 96 weeks	Change in Monocular and Binocular Reading Performance measured in words/min
Geographic Atrophy (GA)	Up to 96 weeks	Change from baseline in area of Geographic Atrophy, as assessed by Fundus Auto Fluoresence measured in mm2

Trial Locations

Locations (71)

Retinal Research Institute (retina consultants of AZ); 🇺🇸 Phoenix, Arizona, United States

Retina Centers PC; 🇺🇸 Tucson, Arizona, United States

Retina Vitreous Associates Medical Group; 🇺🇸 Beverly Hills, California, United States

Byers Eye Institute at Stanford; 🇺🇸 Palo Alto, California, United States

Retina Health Center; 🇺🇸 Fort Myers, Florida, United States

Retina Vitreous Associates of Florida; 🇺🇸 Saint Petersburg, Florida, United States

Southeast Retina Center; 🇺🇸 Augusta, Georgia, United States

Georgia Retina PC; 🇺🇸 Marietta, Georgia, United States

University Retina Macula Associates PC; 🇺🇸 Lemont, Illinois, United States

Midwest Eye Institute Northside; 🇺🇸 Indianapolis, Indiana, United States

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