A Phase 2, Multicentre, Randomised, Double-masked, Placebo-controlled, Parallel-group, Dose-range Finding Study, to Assess the Efficacy and Safety of Oral STL303 in Adults With Geographic Atrophy Secondary to Age-related Macular Degeneration
Sitala Bio LTD
Summary
The purpose of this clinical research study is to look at how safe STL303 is and whether it works when given to people with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD). Geographic atrophy secondary to AMD is a condition where cells in the back part of the eye slowly die, causing a blurry, or missing spot in the centre of vision.
Description
This study is designed as a randomized, multi-center, double-masked, dose-range finding study to characterize the efficacy and safety of STL303.
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: The study eye must meet all inclusion criteria. If both eyes meet the inclusion criteria, the eye with the better visual acuity at the Screening visit will be designated as the study eye. If both eyes have the same visual acuity, the right eye will be selected as the study eye. 1. Participants ≥60 years of age at the time of Screening (signing the ICF). 2. Diagnosis of non-exudative AMD in both eyes, with confirmed presence of phenotypic hallmarks of AMD such as hard and/or soft drusen. 3. The GA lesion in the study eye must meet the following criteria as determined by th…
Interventions
- DrugSTL303
STL303 arm participants will receive a specific dose of STL303
- DrugPlacebo
Placebo arm participants will receive placebo
Locations (60)
- California Retina ConsultantsBakersfield, California
- Retina-Vitreous Associates Medical GroupBeverly Hills, California
- Kaiser Permanente - OaklandOakland, California
- Retina Specialists of ColoradoAurora, Colorado
- Retina Group of New England, PCWaterford, Connecticut
- Retina Vitreous Associates of FloridaSt. Petersburg, Florida