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Taking people in AustraliaPhase 1/2

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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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).

ClinicalTrials.gov NCT07668804