Dry Age-related Macular Degeneration, Geographic Atrophy, Macular Atrophy, Macular Degeneration, Retinal Degeneration, Retinal Disease
Conditions
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Gyroscope Therapeutics Limited
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geographic Atrophy (GA) | Up to 96 weeks | Change from baseline in area of Geographic Atrophy, as assessed by Fundus Auto Fluoresence measured in mm2 |
| Colour Fundus (CF) | Up to 96 weeks | Change from baseline in Colour Fundus Photography measured in mm2 |
| Retinal Drusen Volume | 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) | Up to 96 weeks | Change from baseline in ETDRS BCVA reading score |
| Retinal sensitivity | Up to 96 weeks | Change from baseline in retinal sensitivity as assessed by microperimetry |
| 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 |
| Medical Events of Interest (MEI) | Up to 96 weeks | Change from baseline in percentage of Participants with MEI |
| Monocular and Binocular Reading Performance | Up to 96 weeks | Change in Monocular and Binocular Reading Performance measured in words/min |
Countries
Australia, France, Germany, Netherlands, Poland, Spain, United Kingdom, United States
Outcome results
None listed