First in Human Study of BETA-TT8 in wetAge-related Macular Degeneration (wetAMD)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorFilamon LTD
About this trial
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.
Eligibility criteria
Qualifiers
Age 50 years or older.
Subfoveal or juxtafoveal choroidal neovascularisation (CNV) secondary to AMD in the study eye(s).
Stable disease having received three (3) or more previous intravitreal aflibercept 2mg as standard-of-care.
Total CNV lesion area no greater than 12-disc areas.
Disqualifiers
Ocular Exclusion Criteria
Contraindication to intravitreal aflibercept per its approved label, including active ocular or peri-ocular infection or active intraocular inflammation.
Dense fibrosis or scarring within the study eye(s) lesion limiting OCT interpretation.
Severe atrophy involving the fovea.
Trial design
Treatments tested in this trial
- BETA-TT8 ophthalmic gel 3.8% w/v
Treatment groups
24 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov