A Study to Evaluate the Safety and Effect of TO-O-1007 Intravitreal Implant in Subjects With Geographic Atrophy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TO-O-1007 (low-dose), TO-O-1007 (high-dose), Sham injection.
- Who it may be relevant to
- Registry conditions: Geographic Atrophy Due to Age-Related Macular Degeneration. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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)
Overview
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.
Detailed description
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.
Interventions
- Drug TO-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. - Drug TO-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. - Procedure Sham injection
Sham injection: No injection is given. It is a sham injection to keep the participant masked.
Primary outcome measures
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to 6 months treatment duration]
Secondary outcome measures (3)
- Geographic Atrophy Lesion Growth [Time frame: Baseline, Week 12, and Week 24.]
- Visual Function Assessments [Time frame: Week 12 and Week 24.]
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Australia · 3 centers
- Retina & Eye Consultants — Hurstville
- Sydney Retina Clinic & Day Surgery — Sydney
- Launceston Eye Doctors — Launceston
Identifiers
NCT: NCT07668804 · TO-I-1007