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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TO-O-1007 Low-Dose Cohort (phase I) | Experimental | 3 participants will receive TO-O-1007 (low-dose) |
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| TO-O-1007 High-Dose Cohort (phase I) | Experimental | 3 participants will receive TO-O-1007 (high-dose) |
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| TO-O-1007 Low-Dose Arm 1 (phase IIa) | Experimental | 10 participants will receive TO-O-1007 (low-dose) |
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| TO-O-1007 High-Dose Arm 2 (phase IIa) | Experimental | 10 participants will receive TO-O-1007 (high-dose) |
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| TO-O-1007 Sham Arm 3 (phase IIa) | Sham Comparator | 5 participants will receive a sham injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number 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. | Up to 6 months treatment duration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 12, and Week 24. |
| Visual Function Assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weian Chien | Contact | +886 (2) 2790-6566 | weian@metagone.com.tw | |
| Chung-Hsin Tsai | Contact | +886 (2) 2790-6566 | brian@metagone.com.tw |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Andrew Chang | Sydney Retina Clinic & Day Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina & Eye Consultants | Recruiting | Hurstville | New South Wales (nsw) | 2220 | Australia |
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This is a Phase I/IIa interventional clinical trial evaluating the safety, tolerability, and preliminary efficacy of TO-O-1007, a biodegradable sustained-release intravitreal implant, in patients with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD). Phase I is an open-label, single ascending dose study enrolling 6 participants across low- and high-dose cohorts, with Safety Review Committee (SRC) oversight before dose escalation. Phase IIa is a randomized, single-masked, proof-of-activity study enrolling 25 participants assigned to low-dose TO-O-1007, high-dose TO-O-1007, or sham control. Participants will be followed for 6 months plus 1 month of safety follow-up.
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Phase IIa: single masked (25 Participants)
| 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. |
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| Sham injection | Procedure | Sham injection: No injection is given. It is a sham injection to keep the participant masked. |
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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. |
| Week 12 and Week 24. |
| Exposure endpoint (only for phase I) | Plasma concentrations of TO-O-1007 | Day 1 pre-dose, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 28 post first dosing. |
| Sydney Retina Clinic & Day Surgery | Recruiting | Sydney | New South Wales (nsw) | 2000 | Australia |
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| Launceston Eye Doctors | Recruiting | Launceston | Tasmania (tas) | 7250 | Australia |
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| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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