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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
31
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): Participants will receive two TO-O-1007 implants administered by intravitreal injection into the study eye.
Sham injection: No injection is given. It is a sham injection to keep the participant masked.
Retina & Eye Consultants
Hurstville, New South Wales (nsw), Australia
RECRUITINGSydney Retina Clinic & Day Surgery
Sydney, New South Wales (nsw), Australia
RECRUITINGLaunceston Eye Doctors
Launceston, Tasmania (tas), Australia
RECRUITINGNumber of Participants with Treatment-Emergent Adverse Events (TEAEs)
Number and percentage of participants experiencing at least one treatment-emergent adverse event, including serious adverse events and adverse events of special interest.
Time frame: Up to 6 months treatment duration
Geographic Atrophy Lesion Growth
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.
Time frame: Baseline, Week 12, and Week 24.
Visual Function Assessments
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.
Time frame: Week 12 and Week 24.
Exposure endpoint (only for phase I)
Plasma concentrations of TO-O-1007
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.
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