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First in Human Study of BETA-TT8 in wetAge-related Macular Degeneration (wetAMD)
Sponsor: Filamon LTD
Summary
This is a first-in-human clinical trial evaluating the safety and tolerability of BETA-TT8 Ophthalmic Gel in people with wet age-related macular degeneration (AMD). Approximately 24 participants with stable wet AMD who have previously received at least three anti- Vascular Endothelial Growth Factor (anti -VEGF) injections will use the eye gel for up to 12 weeks at one of three dosing schedules (once, twice, or three times daily). Standard anti-VEGF treatment (aflibercept) will remain available if needed during the study. Participants who complete the initial 12-week treatment period may be invited to continue in an extension phase for up to 12 months to collect additional safety and treatment information.
Official title: A Phase Ib/IIa, First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, and Exploratory Activity of BETA-TT8 Ophthalmic Gel 3.8% in Patients With Neovascular (Wet) Age-related Macular Degeneration (wetAMD)
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-09
Completion Date
2027-09
Last Updated
2026-08-14
Healthy Volunteers
No
Interventions
BETA-TT8 ophthalmic gel 3.8% w/v
A selective small-molecule inhibitor of the MEK/ERK (MAPK) signalling pathway, topical ophthalmic gel.
Locations (4)
Central Coast Eye Specialist
Gosford, New South Wales, Australia
Sydney Eye Hospital
Sydney, New South Wales, Australia
Sydney West Retina
Westmead, New South Wales, Australia
Cerulea Clinical Trials
East Melbourne, Victoria, Australia