Clinical Trials in Australia / NCT07766473
Starting soon
Phase 1/2
First in Human Study of BETA-TT8 in wetAge-related Macular Degeneration (wetAMD)
NCT07766473 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
Neovascular (Wet) Age-Related Macular Degeneration
Investigational drug(s) / intervention(s)
BETA-TT8 ophthalmic gel 3.8% w/v
BETA-TT8 ophthalmic gel 3.8% w/v: A selective small-molecule inhibitor of the MEK/ERK (MAPK) signalling pathway, topical ophthalmic gel.
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.
Eligibility
Inclusion Criteria:
* 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 Criteria:
* 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.
* 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.
* 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.
Primary outcome measure(s)
- To evaluate the safety of topical BETA-TT8 based on TEAEs. — 12 weeks
• Incidence of treatment-emergent adverse events (TEAEs) and ocular TEAEs through Week 12, coded using MedDRA and graded per Common Terminology Criteria for Adverse Events (CTCAE) v5.0. - To evaluate the safety of topical BETA-TT8 based on DLTs. — 12 weeks
• Incidence of dose-limiting toxicities (DLTs) within pre-defined evaluation windows. A DLT is defined as any of the following events considered at least possibly related to BETA-TT8. Systemic DLTs; * Any Grade 3 or higher adverse event per CTCAE v5.0. * Any drug-related Grade 2 adverse event sustained for more than 7 days. * ALT or AST greater than 3× ULN with total bilirubin greater than 1.5× ULN. * Grade 3 or higher haematological toxicity. * QTcF greater than 500 ms, or an increase in QTcF greater than 60 ms from baseline, confirmed on repeat ECG. Ocular DLTs; * Clinically significant corneal toxicity (Grade 2 or higher on NEI/Oxford scale sustained more than 7 days, or any Grade 3 finding). * Anterior chamber inflammation above the pre-specified grading threshold. * Clinically significant IOP increase, defined as an increase greater than 10 mmHg from baseline AND an absolute IOP greater than 30 mmHg, confirmed on repeat measurement. * Clinically meaningful decrease in BCVA - To evaluate the safety of topical BETA-TT8 based on clinically significant ocular findings. — 12 weeks
Incidence of clinically significant ocular findings on slit-lamp and fundoscopic examination (cornea, conjunctiva, anterior chamber, lens, vitreous, retina). Corneal epithelial findings (including punctate keratopathy) are specifically monitored as a precaution for topical ocular small molecules. - To evaluate the safety of topical BETA-TT8 based on intraocular pressure changes. — 12 weeks
Incidence of clinically significant intraocular pressure (IOP) changes, defined as an increase greater than 10 mmHg from baseline or absolute IOP greater than 30 mmHg. - To evaluate the safety of topical BETA-TT8 based on corneal staining abnormalities. — 12 weeks
Incidence of corneal epithelial defects/staining abnormalities graded per National Eye Institute (NEI) or Oxford scale. - To evaluate the tolerability of topical BETA-TT8 based on reasons for discontinuations. — 12 weeks
Incidence of treatment discontinuations due to adverse events. - To evaluate the safety of topical BETA-TT8 based on TEAEs. — 12 weeks
• Severity of treatment-emergent adverse events (TEAEs) and ocular TEAEs through Week 12, coded using MedDRA and graded per Common Terminology Criteria for Adverse Events (CTCAE) v5.0. - To evaluate the safety of topical BETA-TT8 based on TEAEs. — 12 weeks
• Relationship of treatment-emergent adverse events (TEAEs) and ocular TEAEs through Week 12, coded using MedDRA and graded per Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Central Coast Eye Specialist | Gosford | New South Wales | |
| Sydney Eye Hospital | Sydney | New South Wales | |
| Sydney West Retina | Westmead | New South Wales | |
| Cerulea Clinical Trials | East Melbourne | Victoria |
More Filamon LTD trials in Australia
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07766473 on ClinicalTrials.gov ↗ ← All trials in Australia