TO-O-1007 Eye Implant for Geographic Atrophy Caused by Age-Related Macular Degeneration
Tests an eye implant, TO-O-1007, in people with geographic atrophy from macular degeneration.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Safety and Effect of TO-O-1007 Intravitreal Implant in Subjects With Geographic Atrophy
Key facts
- Where
- Hurstville, Launceston, and Sydney, AustraliaSee the 3 sites
- Phase
- Phase 1/2
Where in Australia
- Retina & Eye ConsultantsHurstville, AustraliaTaking people
- Launceston Eye DoctorsLaunceston, AustraliaTaking people
- Sydney Retina Clinic & Day SurgerySydney, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Theratocular Biotek Co.
- Trial code
- NCT07668804
- Record updated
- 25 June 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Prior AMD treatment or active/secondary CNV in the study eye; Current/prior uveitis; Recent anti-complement therapy; Use of prohibited medications, investigational products, or immunosuppressive therapies; Recent participation in intravitreal, GA, or investigational treatment studies; Pregnant or nursing women; High myopia (>8 D or axial length >27 mm).