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

RecruitingPhase 1, Phase 2Ages 50 Years - anyAllTheratocular Biotek Co.
NCT07668804 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adults ≥50 years, able to provide informed consent and comply with study procedures. 2. Non-foveal GA secondary to dry AMD, confirmed by the central reading center. 3. Total GA area 2.5-17.5 mm² by FAF (≥1.25 mm² for at least one lesion if multifocal). 4. BCVA ≥24 ETDRS letters (\~20/320 Snellen) in the study eye. 5. IOP ≤21 mmHg in the study eye. Exclusion Criteria: 1. Recent participation in intravitreal, GA, or investigational treatment studies. 2. Pregnant or nursing women. 3. High myopia (\>8 D or axial length \>27 mm). 4. Prior AMD treatment or active/secondary CNV in the study eye. 5. Current/prior uveitis. 6. Recent anti-complement therapy. 7. Use of prohibited medications, investigational products, or immunosuppressive therapies.
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What it tests

  • TO-O-1007 (low-dose)
  • TO-O-1007 (high-dose)
  • Sham injection
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Where

3 sites
Retina & Eye Consultants
Hurstville, Australia
Sydney Retina Clinic & Day Surgery
Sydney, Australia
Launceston Eye Doctors
Launceston, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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