First test of BETA-TT8 eye gel in wet age-related macular degeneration
Tests BETA-TT8 eye gel for safety in people with wet macular degeneration.
Plain-language title generated from the registry record
Registry title: First in Human Study of BETA-TT8 in wetAge-related Macular Degeneration (wetAMD)
Key facts
- Where
- East Melbourne, Gosford, Sydney, and Westmead, AustraliaSee the 4 sites
- Phase
- Phase 1/2
Where in Australia
- Cerulea Clinical TrialsEast Melbourne, AustraliaNo longer taking part
- Central Coast Eye SpecialistGosford, AustraliaNo longer taking part
- Sydney Eye HospitalSydney, AustraliaNo longer taking part
- Sydney West RetinaWestmead, AustraliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Filamon LTD
- Trial code
- NCT07766473
- Record updated
- 18 September 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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; BCVA in the study eye between 24 and 78 ETDRS letters inclusive; Suitable for intravitreal aflibercept rescue per its approved label; Able to self-administer eye drops or has a trained caregiver able to administer drops at home; Willing and able to comply with the protocol-defined visit schedule; Signed informed consent.
Exclusion: 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; Subretinal haemorrhage involving or obscuring the fovea; Subretinal fibrosis involving more than 50% of the lesion area; Pigment epithelial detachment involving more than 50% of the CNV lesion; Confounding retinal disease, including diabetic retinopathy, retinal vein occlusion, or myopic degeneration; Significant corneal disease that would complicate topical safety interpretation; Prior subfoveal laser photocoagulation, photodynamic therapy, or ocular radiation in the study eye; Uncontrolled glaucoma or IOP greater than 25 mmHg at screening; Other Exclusion Criteria; Inability or unwillingness to comply with study procedures or dosing requirements; Cognitive impairment or insufficient home support that may compromise proper administration of study treatment; Participation in another investigational study within 30 days of screening; Systemic Exclusion Criteria; Clinically meaningful ECG abnormality or QTcF concern at baseline (QTcF greater than 460 ms in men or greater than 480 ms in women); Current use of QT-prolonging medications per a pre-specified list; Current use of medications with known MEK or MAPK pathway activity; Clinically significant hepatic, renal, cardiovascular, or haematological disease; Known hypersensitivity to any component of the BETA-TT8 formulation or to aflibercept; Active malignancy or history of malignancy requiring treatment within the prior 5 years. Cancers considered to be cured (eg. prostatectomy or radiation for prostate cancer, adjuvant treatment for breast cancer) or treated non-metastatic skin or melanoma are excepted; Pregnancy, breastfeeding, or inadequate contraception during the study and for 30 days after last dose of BETA-TT8.