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Tests treatment safety and results for Geographic Atrophy Due to Age-Related Macular...
Official title A Study to Evaluate the Safety and Effect of TO-O-1007 Intravitreal Implant in Subjects With Geographic Atrophy
ClinicalTrials.gov ID: NCT07668804
What this study is testing
What is TO-O-1007 (low-dose)?
TO-O-1007 (low-dose) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for geographic atrophy due to age-related macular degeneration.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join 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 likely can't join 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.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hurstville, New South Wales (nsw), Australia
- Sydney, New South Wales (nsw), Australia
- Launceston, Tasmania (tas), Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hurstville, New South Wales (nsw), Australia; Sydney, New South Wales (nsw), Australia; Launceston, Tasmania (tas), Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.