Geographic Atrophy Due to Age-Related Macular DegenerationPhase 1/2NCT07668804
A Study to Evaluate the Safety and Effect of TO-O-1007 Intravitreal Implant in Subjects With Geographic Atrophy
A Phase 1/2 study testing TO-O-1007 (low-dose) and TO-O-1007 (high-dose) in people with Geographic Atrophy Due to Age-Related Macular Degeneration, run by Theratocular Biotek Co. at 3 sites in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Geographic Atrophy Due to Age-Related Macular Degeneration
- What is being tested?
- TO-O-1007 (low-dose) and TO-O-1007 (high-dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 3 sitesAustralia
- Study dates
- 2 Jun 2026to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Recruiting
Retina & Eye Consultants
Hurstville, New South Wales (nsw), 2220
Amanda Feeney, +61 2 9570 1622, amanda.feeney@retinaandeye.com.au
Dr. Derek Chan
- Recruiting
Launceston Eye Doctors
Launceston, Tasmania (tas), 7250
Karen Hutt, +61 3 6334 0000, khutt@launcestoneyedoctors.com.au
Dr. Tze-Yo Toh
- Recruiting
Sydney Retina Clinic & Day Surgery
Sydney, New South Wales (nsw), 2000
Lifei Chen, +61 2 9221 3755, Lifei.chen@cureos.com.au
Dr. Andrew Chang
About this study
Official title: 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.
Read the 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.
- Being tested
- TO-O-1007 (low-dose), TO-O-1007 (high-dose), Sham injection
- Keywords
- Geographic Atrophy, TO-O-1007, Intravitreal Implant, TO-I-1007
- Medical subject headings
- Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 (high-dose)Drug
TO-O-1007 (high-dose): Participants will receive two TO-O-1007 implants administered by intravitreal injection into the study eye.
Sham injectionProcedure or surgery
Sham injection: No injection is given. It is a sham injection to keep the participant masked.
| Study group | Role | What they receive |
|---|---|---|
| TO-O-1007 Low-Dose Cohort (phase I) | Experimental | 3 participants will receive TO-O-1007 (low-dose) Receives: Drug: TO-O-1007 (low-dose) |
| TO-O-1007 High-Dose Cohort (phase I) | Experimental | 3 participants will receive TO-O-1007 (high-dose) Receives: 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) Receives: 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) Receives: Drug: TO-O-1007 (high-dose) |
| TO-O-1007 Sham Arm 3 (phase IIa) | Sham comparator | 5 participants will receive a sham injection. Receives: Procedure: Sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months treatment duration
Secondary outcomes (3)
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.
Measured: 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.
Measured: Week 12 and Week 24.
Exposure endpoint (only for phase I)
Plasma concentrations of TO-O-1007
Measured: Day 1 pre-dose, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 28 post first dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start2 Jun 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic Atrophy Due to Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theratocular Biotek Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Andrew Chang, Principal investigator, Sydney Retina Clinic & Day Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668804
- Sponsor's protocol ID
- TO-I-1007
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07668804
- Acronym / sponsor ID
- TO-I-1007
- Keywords
- Geographic Atrophy, TO-O-1007, Intravitreal Implant, TO-I-1007
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Theratocular Biotek Co.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| TO-O-1007 Low-Dose Cohort (phase I) | Experimental | Drug: TO-O-1007 (low-dose)3 participants will receive TO-O-1007 (low-dose) |
| TO-O-1007 High-Dose Cohort (phase I) | Experimental | Drug: TO-O-1007 (high-dose)3 participants will receive TO-O-1007 (high-dose) |
| TO-O-1007 Low-Dose Arm 1 (phase IIa) | Experimental | Drug: TO-O-1007 (low-dose)10 participants will receive TO-O-1007 (low-dose) |
| TO-O-1007 High-Dose Arm 2 (phase IIa) | Experimental | Drug: TO-O-1007 (high-dose)10 participants will receive TO-O-1007 (high-dose) |
| TO-O-1007 Sham Arm 3 (phase IIa) | Sham comparator | Procedure: Sham injection5 participants will receive a sham injection. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 Low-Dose Arm 1 (phase IIa), TO-O-1007 Low-Dose Cohort (phase I) |
| 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. | Drug | TO-O-1007 High-Dose Arm 2 (phase IIa), TO-O-1007 High-Dose Cohort (phase I) |
| Sham injectionSham injection: No injection is given. It is a sham injection to keep the participant masked. | Procedure or surgery | TO-O-1007 Sham Arm 3 (phase IIa) |
Primary outcome
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.
3 secondary outcomes
Geographic Atrophy Lesion Growth
Time frame: Baseline, Week 12, and Week 24.
Visual Function Assessments
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Andrew Chang principal investigator
Sydney Retina Clinic & Day Surgery
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TO-O-1007 (low-dose) and TO-O-1007 (high-dose) in people with Geographic Atrophy Due to Age-Related Macular Degeneration, run by Theratocular Biotek Co. at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weian Chien (+886 (2) 2790-6566, weian@metagone.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to 6 months treatment duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.