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

NCT07766473 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-08-14

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Filamon LTD

    lead INDUSTRY

Principal Investigators

  • Hemal Mehta, MBBS MD, FRCOphth FRANZCO · Central Coast Eye Specialists

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-03-31
Completion
2027-09-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07766473 on ClinicalTrials.gov