NCT07668804RecruitingPhase 1/2
A Study to Evaluate the Safety and Effect of TO-O-1007 Intravitreal Implant in Subjects With Geographic Atrophy
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)
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 31 (estimated)
- First submitted
- 16 Jun 2026
- Start date
- 2 Jun 2026
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Theratocular Biotek Co.
- Diseases
- Macular degeneration
- NCT number
- NCT07668804
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 31
- From 2 Jun 2026 to the primary completion date, 31 Aug 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Recent participation in intravitreal, GA, or investigational treatment studies.
- Pregnant or nursing women.
- High myopia (\>8 D or axial length \>27 mm).
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Retina & Eye Consultants Coordinator of this site? Confirm its status | Hurstville | Australia | Recruiting |
| Launceston Eye Doctors Coordinator of this site? Confirm its status | Launceston | Australia | Recruiting |
| Sydney Retina Clinic & Day Surgery Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.