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

Overview

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

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 8, 2023

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.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • Colour Fundus (CF)
    • Time Frame: Up to 96 weeks
    • Change from baseline in Colour Fundus Photography measured in mm2
  • Retinal Drusen Volume
    • Time Frame: Up to 96 weeks
    • Change from baseline in retinal drusen volume measured in mm3
  • 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
  • Retinal sensitivity
    • Time Frame: Up to 96 weeks
    • Change from baseline in retinal sensitivity as assessed by microperimetry
  • 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
  • Medical Events of Interest (MEI)
    • Time Frame: Up to 96 weeks
    • Change from baseline in percentage of Participants with MEI
  • Monocular and Binocular Reading Performance
    • Time Frame: Up to 96 weeks
    • Change in Monocular and Binocular Reading Performance measured in words/min

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gyroscope Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Gyroscope Therapeutics, +441438532142, clinicaltrials@gyroscopetx.com

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