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

NCT07668804 | Recruiting Phase 1 DMC

• 1 other identifier: TO-I-1007
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Geographic Atrophy Due to Age-Related Macular Degeneration

Keywords

Geographic Atrophy; TO-O-1007; Intravitreal Implant; TO-I-1007

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Geographic Atrophy Lesion Growth

  Baseline, Week 12, and Week 24.

• Visual Function Assessments

  Week 12 and Week 24.

• Exposure endpoint (only for phase I)

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

Study Arms (5)

TO-O-1007 Low-Dose Cohort (phase I)

EXPERIMENTAL

3 participants will receive TO-O-1007 (low-dose)

Drug: TO-O-1007 (low-dose)

TO-O-1007 High-Dose Cohort (phase I)

EXPERIMENTAL

3 participants will receive TO-O-1007 (high-dose)

Drug: TO-O-1007 (high-dose)

TO-O-1007 Low-Dose Arm 1 (phase IIa)

EXPERIMENTAL

10 participants will receive TO-O-1007 (low-dose)

Drug: TO-O-1007 (low-dose)

TO-O-1007 High-Dose Arm 2 (phase IIa)

EXPERIMENTAL

10 participants will receive TO-O-1007 (high-dose)

Drug: TO-O-1007 (high-dose)

TO-O-1007 Sham Arm 3 (phase IIa)

SHAM COMPARATOR

5 participants will receive a sham injection.

Procedure: Sham injection

Interventions

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 Low-Dose Arm 1 (phase IIa); TO-O-1007 Low-Dose Cohort (phase I)

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.

TO-O-1007 High-Dose Arm 2 (phase IIa); TO-O-1007 High-Dose Cohort (phase I)

Sham injection PROCEDURE

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

TO-O-1007 Sham Arm 3 (phase IIa)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Theratocular Biotek Co.: lead

Study Sites (3)

Retina & Eye Consultants

Hurstville, New South Wales (nsw), 2220, Australia

RECRUITING

Sydney Retina Clinic & Day Surgery

Sydney, New South Wales (nsw), 2000, Australia

RECRUITING

Launceston Eye Doctors

Launceston, Tasmania (tas), 7250, Australia

RECRUITING

MeSH Terms

Conditions

Geographic Atrophy

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Dr. Andrew Chang

  Sydney Retina Clinic & Day Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weian Chien

CONTACT

+886 (2) 2790-6566; weian@metagone.com.tw

Chung-Hsin Tsai

CONTACT

+886 (2) 2790-6566; brian@metagone.com.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Phase IIa: single masked (25 Participants)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 25, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Locations

AU (3)