A Study in Adults With Geographic Atrophy
ConditionGeographic Atrophy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorSitala Bio LTD
About this trial
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.
Eligibility criteria
Qualifiers
Participants ≥60 years of age at the time of Screening (signing the ICF).
Diagnosis of non-exudative AMD in both eyes, with confirmed presence of phenotypic hallmarks of AMD such as hard and/or soft drusen.
Total GA area must be ≥2.5 and ≤10.16 mm2 (1 and 4 DA, respectively) as measured using SD-OCT.
If GA is multifocal, at least one focal lesion must be ≥1.25 mm2 (0.5 DA), with the overall aggregate area of GA, as specified above in 3a.
Disqualifiers
Atrophic retinal disease of causality other than AMD including myopia-related maculopathy and macular dystrophies such as pattern dystrophy and Stargardt disease in either eye.
Evidence of ongoing exudative AMD, polypoidal choroidal vasculopathy, or macular neovascularisation in either eye by history, OCT, fluorescein angiography (FA) or optical coherence tomography angiography (OCTA) as determined by the Reading Centre (prior IVT treatment for CNV is permitted in the fellow eye so long as the last injection was more than two years previously).
Previous treatment with any ocular photodynamic therapy or laser coagulation to the macula in the study eye.
Presence of active/current retinal vein occlusion in the study eye.
Trial design
Treatments tested in this trial
- STL303
- Placebo
Treatment groups
300 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov