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

June 21, 2026 updated by: Theratocular Biotek Co.

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

31

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales (nsw)
      • Hurstville, New South Wales (nsw), Australia, 2220
        • Recruiting
        • Retina & Eye Consultants
        • Principal Investigator:
          • Dr. Derek Chan
        • Contact:
      • Sydney, New South Wales (nsw), Australia, 2000
        • Recruiting
        • Sydney Retina Clinic & Day Surgery
        • Principal Investigator:
          • Dr. Andrew Chang
        • Contact:
    • Tasmania (tas)
      • Launceston, Tasmania (tas), Australia, 7250
        • Recruiting
        • Launceston Eye Doctors
        • Contact:
        • Principal Investigator:
          • Dr. Tze-Yo Toh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adults ≥50 years, able to provide informed consent and comply with study procedures.
  2. Non-foveal GA secondary to dry AMD, confirmed by the central reading center.
  3. Total GA area 2.5-17.5 mm² by FAF (≥1.25 mm² for at least one lesion if multifocal).
  4. BCVA ≥24 ETDRS letters (~20/320 Snellen) in the study eye.
  5. IOP ≤21 mmHg in the study eye.

Exclusion Criteria:

  1. Recent participation in intravitreal, GA, or investigational treatment studies.
  2. Pregnant or nursing women.
  3. High myopia (>8 D or axial length >27 mm).
  4. Prior AMD treatment or active/secondary CNV in the study eye.
  5. Current/prior uveitis.
  6. Recent anti-complement therapy.
  7. Use of prohibited medications, investigational products, or immunosuppressive therapies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TO-O-1007 Low-Dose Cohort (phase I)
3 participants will receive TO-O-1007 (low-dose)
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.
Experimental: TO-O-1007 High-Dose Cohort (phase I)
3 participants will receive TO-O-1007 (high-dose)
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.
Experimental: TO-O-1007 Low-Dose Arm 1 (phase IIa)
10 participants will receive TO-O-1007 (low-dose)
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.
Experimental: TO-O-1007 High-Dose Arm 2 (phase IIa)
10 participants will receive TO-O-1007 (high-dose)
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.
Sham Comparator: TO-O-1007 Sham Arm 3 (phase IIa)
5 participants will receive a sham injection.
Procedure: Sham injection
Sham injection: No injection is given. It is a sham injection to keep the participant masked.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to 6 months treatment duration
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geographic Atrophy Lesion Growth
Time Frame: Baseline, Week 12, and Week 24.
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
Time Frame: Week 12 and Week 24.
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)
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theratocular Biotek Co.

Investigators

  • Principal Investigator: Dr. Andrew Chang, Sydney Retina Clinic & Day Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 21, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 21, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TO-I-1007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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