A Study to Evaluate the Safety and Effect of TO-O-1007 Intravitreal Implant in Subjects With Geographic Atrophy
Recruiting
Phase 1
Phase 2
Interventional Study
Geographic Atrophy Due to Age-Related Macular Degeneration
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 50 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 31 (estimated)
- Sponsor
- Theratocular Biotek Co. · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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 lette…
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