A Phase I/IIa Trial to Evaluate the Safety, Tolerability and Efficacy After Single Administration of TO-O-1007 (Intravitreal Implant) in Subjects With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
This study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of TO-O-1007, a biodegradable sustained-release intravitreal implant, for the treatment of Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD). A long-acting intravitreal implant providing sustained delivery of API over 6 months may slow the progression of GA lesions while reducing treatment burden associated with frequent intravitreal injections. TO-O-1007 may offer a convenient treatment option with the potential to preserve retinal structure and visual function while maintaining an acceptable safety profile.
• Adults ≥50 years, able to provide informed consent and comply with study procedures.
• Non-foveal GA secondary to dry AMD, confirmed by the central reading center.
• Total GA area 2.5-17.5 mm² by FAF (≥1.25 mm² for at least one lesion if multifocal).
• BCVA ≥24 ETDRS letters (\
⁃ 20/320 Snellen) in the study eye.
• IOP ≤21 mmHg in the study eye.