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

Condition studied

Geographic Atrophy Secondary to Age-related Macular Degeneration

Investigational medicinal product(s)

Every trial of STL303 across our registers →

Eligibility

Primary endpoint

Rate of change in the area of photoreceptor loss (defined as an EZ to RPE thickness of 0 μm) assessed on SD-OCT at Week 52

Endpoint detail

Treatment-emergent adverse events and serious adverse events during the study, Changes in vital signs, physical examination, weight, ECG, safety clinical laboratory parameters (haematology, clinical chemistry, coagulation, and urinalysis) from baseline throughout the study, Change from baseline in mean retinal sensitivity in the participant-customised perilesional grid area as measured by mesopic microperimetry at Weeks 52 and, Development of new scotomatous points in the participant-customised perilesional grid area as measured by mesopic microperimetry at Weeks 52 and 104, Rate of change in the area of photoreceptor loss (defined as an EZ to RPE thickness of 0 μm) assessed on SD-OCT at Weeks 78 and 104, Change from baseline to Weeks 52 and 104 in LLVA score, measured using ETDRS charts under standardised mesopic conditions with a 2.0 log unit neutral density filter, Change from baseline to Weeks 52, 78, and 104 in square root GA lesion size in the study eye as measured by OCT, Change from baseline to Weeks 52, 78, and 104 in square root GA lesion size in the study eye as measured by FAF, Change from baseline to Weeks 52 and 104 in the NEI-VFQ-25 composite score (range: 0-100), where higher scores indicate better vision-related quality of life, Plasma PK in a subset of participants (up to 20%, evenly distributed between active and placebo groups) o Plasma PK parameters, including, but not limited to Cmax,ss, Tmax,ss, AUCtau, Ctrough,ss at Week 4 o Plasma PK parameters, including, but not limited to Ctrough,ss and C2,ss at Weeks 4, 12, 26, 52, 78, and 104, Plasma PK in the remaining participants (around 80%) o Plasma PK parameters, including, but not limited to Ctrough,ss at Weeks 4, 12, 26, 52, 78, and 104