NCT07668804 A Study to Evaluate the Safety and Effect of TO-O-1007 Intravitreal Implant in Subjects With Geographic Atrophy
| NCT ID | NCT07668804 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Theratocular Biotek Co. |
| Condition | Geographic Atrophy Due to Age-Related Macular Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 31 participants |
| Start Date | 2026-06-02 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 31 participants in total. It began in 2026-06-02 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 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.
Contact & Investigator
Dr. Andrew Chang
PRINCIPAL INVESTIGATOR
Sydney Retina Clinic & Day Surgery
Frequently Asked Questions
Who can join the NCT07668804 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Geographic Atrophy Due to Age-Related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07668804 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07668804 currently recruiting?
Yes, NCT07668804 is actively recruiting participants. Contact the research team at weian@metagone.com.tw for enrollment information.
Where is the NCT07668804 trial being conducted?
This trial is being conducted at Hurstville, Australia, Sydney, Australia, Launceston, Australia.
Who is sponsoring the NCT07668804 clinical trial?
NCT07668804 is sponsored by Theratocular Biotek Co.. The principal investigator is Dr. Andrew Chang at Sydney Retina Clinic & Day Surgery. The trial plans to enroll 31 participants.