Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Evaluate the Safety and Effect of TO-O-1007 Intravitreal Implant in Subjects With Geographic Atrophy
Sponsor: Theratocular Biotek Co.
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.
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)
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
31
Start Date
2026-06-02
Completion Date
2027-12-31
Last Updated
2026-06-25
Healthy Volunteers
No
Interventions
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.
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 injection
Sham injection: No injection is given. It is a sham injection to keep the participant masked.
Locations (3)
Retina & Eye Consultants
Hurstville, New South Wales (nsw), Australia
Sydney Retina Clinic & Day Surgery
Sydney, New South Wales (nsw), Australia
Launceston Eye Doctors
Launceston, Tasmania (tas), Australia