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NCT Number: NCT07668804

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

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.

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Key information

Conditions

Geographic Atrophy Due to Age-Related Macular Degeneration Eye Diseases Geographic Atrophy Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Retina & Eye Consultants, Hurstville, New South Wales (nsw), Australia

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About this study

TO-O-1007 is a biodegradable sustained-release intravitreal implant, that is injected into the vitreous cavity of the eye. The implant is designed to gradually degrade over time, providing sustained ocular delivery of API for up to 6 months following a single administration. By continuously inhibiting C3/C5 activation, TO-O-1007 is intended to slow the progression of Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD), with the goal of preserving retinal structure and visual function. In this study, TO-O-1007 will be evaluated for its safety, tolerability, pharmacokinetics, and preliminary efficacy to determine whether it may offer a durable treatment option that reduces treatment burden compared with currently available therapies requiring more frequent intravitreal injections.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

TO-O-1007 (low-dose)

Drug

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

TO-O-1007 (high-dose)

Drug

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

Sham injection

Procedure

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

Primary outcomes

  1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to 6 months treatment duration

    Number and percentage of participants experiencing at least one treatment-emergent adverse event, including serious adverse events and adverse events of special interest.

Secondary outcomes

  1. Geographic Atrophy Lesion Growth

    Time frame: Baseline, Week 12, and Week 24.

    Change in the growth rate of square root-transformed total Geographic Atrophy lesion area in the study eye, assessed by fundus autofluorescence (FAF) imaging through Week 24.

  2. Visual Function Assessments

    Time frame: Week 12 and Week 24.

    Mean change from baseline in BCVA, LL-BCVA, and low-luminance deficit (LLD), assessed using ETDRS charts under photopic and low-luminance conditions through Week 24.

  3. Exposure endpoint (only for phase I)

    Time frame: Day 1 pre-dose, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 28 post first dosing.

    Plasma concentrations of TO-O-1007

Study contacts

Contact information is provided by the study sponsor or research team.

Chung-Hsin Tsai

CONTACT

[email protected]

+886 (2) 2790-6566

Weian Chien

CONTACT

[email protected]

+886 (2) 2790-6566

Sponsors and collaborators

Lead sponsor

Theratocular Biotek Co.

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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