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

NCT07668804 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-06-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Theratocular Biotek Co.

    lead INDUSTRY

Principal Investigators

  • Dr. Andrew Chang · Sydney Retina Clinic & Day Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-02
Primary Completion
2027-08-31
Completion
2027-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07668804 on ClinicalTrials.gov