Evaluation of TO-O-1007 Intravitreal Implant for Treating Geographic Atrophy in Age-Related Macular Degeneration

What this Trial Is About

Researchers are evaluating TO-O-1007, a biodegradable sustained-release intravitreal implant, for the treatment of Geographic Atrophy GA caused by Age-related Macular Degeneration AMD. The study is designed to assess the safety, tolerability, pharmacokinetics, and early effectiveness of this implant. TO-O-1007 aims to provide a long-lasting treatment option that may slow the progression of GA lesions and reduce the need for frequent eye injections. Participants will receive one of several treatments a low-dose or high-dose TO-O-1007 implant injected into the eye, or a sham injection to maintain masking. The implant gradually degrades, releasing medication over approximately six months. This study includes two phases Phase I and Phase IIa with different dosing groups to evaluate the implants effects and safety compared to a sham treatment. During the study, participants will undergo eye exams to monitor lesion growth and visual function at multiple time points, including baseline, 12 weeks, and 24 weeks. Safety will be closely watched through treatment-emergent adverse event recording up to six months. Pharmacokinetic sampling will be done at several intervals to measure drug exposure. The total study duration extends up to 28 weeks with regular visits for assessments and monitoring of the implants effects on vision and eye health.

A Study to Evaluate the Safety and Effect of TO-O-1007 Intravitreal Implant in Subjects With Geographic Atrophy