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RecruitingPhase 1Phase 2NCT07668804

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)

Sponsor

Theratocular Biotek Co.

Enrollment

31 participants

Start Date

Jun 2, 2026

Study Type

INTERVENTIONAL

Conditions

Geographic Atrophy Due to Age-Related Macular Degeneration

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

Min Age: 50 Years

Inclusion Criteria5

  • 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.

Exclusion Criteria7

  • 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.

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Interventions

DRUGTO-O-1007 (low-dose)

TO-O-1007 (low-dose): Participants will receive one TO-O-1007 implant administered by intravitreal injection into the study eye.

DRUGTO-O-1007 (high-dose)

TO-O-1007 (high-dose): Participants will receive two TO-O-1007 implants administered by intravitreal injection into the study eye.

PROCEDURESham injection

Sham injection: No injection is given. It is a sham injection to keep the participant masked.

Locations(3)

Retina & Eye Consultants

Hurstville, New South Wales (nsw), Australia

Sydney Retina Clinic & Day Surgery

Sydney, New South Wales (nsw), Australia

Launceston Eye Doctors

Launceston, Tasmania (tas), Australia

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NCT07668804