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

Condition(s) studied

Investigational drug(s) / intervention(s)

TO-O-1007 (low-dose): TO-O-1007 (low-dose): Participants will receive one TO-O-1007 implant administered by intravitreal injection into the study eye.

TO-O-1007 (high-dose): TO-O-1007 (high-dose): Participants will receive two TO-O-1007 implants administered by intravitreal injection into the study eye.

Sham injection: Sham injection: No injection is given. It is a sham injection to keep the participant masked.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Number of Participants with Treatment-Emergent Adverse Events (TEAEs) — Up to 6 months treatment duration
  Number and percentage of participants experiencing at least one treatment-emergent adverse event, including serious adverse events and adverse events of special interest.

Trial sites (3)