NCT07766473Not yet recruitingPhase 1/2
First in Human Study of BETA-TT8 in wetAge-related Macular Degeneration (wetAMD)
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)
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 21 Jul 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Filamon LTD
- Diseases
- Macular degeneration
- NCT number
- NCT07766473
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 24
- From 1 Sept 2026 to the primary completion date, 31 Mar 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 illness
- 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.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cerulea Clinical Trials Coordinator of this site? Confirm its status | East Melbourne | Australia | Unknown status |
| Central Coast Eye Specialist Coordinator of this site? Confirm its status | Gosford | Australia | Unknown status |
| Sydney Eye Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Sydney West Retina Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.