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

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Geographic Atrophy Due to Age-Related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT07668804

Run by

Theratocular Biotek Co.

People needed

31

Starts

2026-06-02

Expected to finish

2027-12-31

Last updated by the study team

2026-06-25

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Recent participation in intravitreal, GA, or investigational treatment studies.
• Pregnant or nursing women.
• High myopia (>8 D or axial length >27 mm).
• 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.

Where it is running

• Retina & Eye Consultants — Hurstville, New South Wales (nsw), Australia (enrolling)
• Sydney Retina Clinic & Day Surgery — Sydney, New South Wales (nsw), Australia (enrolling)
• Launceston Eye Doctors — Launceston, Tasmania (tas), Australia (enrolling)

Full record on ClinicalTrials.gov

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