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NOT YET RECRUITING
NCT07766473
PHASE1/PHASE2

First in Human Study of BETA-TT8 in wetAge-related Macular Degeneration (wetAMD)

Sponsor: Filamon LTD

View on ClinicalTrials.gov

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

DRUG

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