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

NCT07766473 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: BETA-TT8-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 4

Brief 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

Neovascular (Wet) Age-Related Macular Degeneration

Keywords

BETA-TT8; wetAMD; Ophthalmic gel; neovascular AMD; ophthalmology

Outcome Measures

Primary Outcomes (8)

• To evaluate the safety of topical BETA-TT8 based on TEAEs.

  • 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.

  12 weeks

• To evaluate the safety of topical BETA-TT8 based on DLTs.

  • 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

  12 weeks

• To evaluate the safety of topical BETA-TT8 based on clinically significant ocular findings.

  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.

  12 weeks

• To evaluate the safety of topical BETA-TT8 based on intraocular pressure changes.

  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.

  12 weeks

• To evaluate the safety of topical BETA-TT8 based on corneal staining abnormalities.

  Incidence of corneal epithelial defects/staining abnormalities graded per National Eye Institute (NEI) or Oxford scale.

  12 weeks

• To evaluate the tolerability of topical BETA-TT8 based on reasons for discontinuations.

  Incidence of treatment discontinuations due to adverse events.

  12 weeks

• To evaluate the safety of topical BETA-TT8 based on TEAEs.

  • 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.

  12 weeks

• To evaluate the safety of topical BETA-TT8 based on TEAEs.

  • 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.

  12 weeks

Secondary Outcomes (5)

• To further characterise ocular safety following repeated topical administration based on preliminary biological activity data.

  12 weeks

• Exploratory-efficacy signals during BETA-TT8 treatment phase.

  12 weeks

• Exploratory-efficacy signals during BETA-TT8 treatment phase.

  12 weeks

• Exploratory-efficacy signals during BETA-TT8 treatment phase.

  12 weeks

• To further characterise ocular safety following repeated topical administration based on preliminary biological activity data.

  12 weeks

Other Outcomes (9)

• To assess systemic exposure effects of BETA-TT8 over the Extension Phase

  12 months

• To assesses potential efficacy of BETA-TT8 over the Extension Phase

  12 months

• To characterise aflibercept injection burden over the 12-month Extension Phase

  12 months

Study Arms (3)

BETA-TT8 Ophthalmic topical gel - Group one

ACTIVE COMPARATOR

One drop, once daily

Drug: BETA-TT8 ophthalmic gel 3.8% w/v

BETA-TT8 Ophthalmic topical gel - Group two

ACTIVE COMPARATOR

One drop, twice daily

Drug: BETA-TT8 ophthalmic gel 3.8% w/v

BETA-TT8 Ophthalmic topical gel - Group three

ACTIVE COMPARATOR

One drop, three times daily

Drug: BETA-TT8 ophthalmic gel 3.8% w/v

Interventions

BETA-TT8 ophthalmic gel 3.8% w/v DRUG

A selective small-molecule inhibitor of the MEK/ERK (MAPK) signalling pathway, topical ophthalmic gel.

BETA-TT8 Ophthalmic topical gel - Group one; BETA-TT8 Ophthalmic topical gel - Group three; BETA-TT8 Ophthalmic topical gel - Group two

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Filamon LTD: lead

Study Sites (4)

Central Coast Eye Specialist

Gosford, New South Wales, 2250, Australia

Location

Sydney Eye Hospital

Sydney, New South Wales, 2000, Australia

Location

Sydney West Retina

Westmead, New South Wales, 2145, Australia

Location

Cerulea Clinical Trials

East Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Hemal Mehta, MBBS MD, FRCOphth FRANZCO

  Central Coast Eye Specialists

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hemal Mehta, MBBS MD, FRCOphth FRANZCO

CONTACT

(02) 4325 2482; HM@ispecialist.org

Sarrvesa Singh

CONTACT

(02) 4325 2482; sarrvesa.singh@retinaclinicaltrials.com.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single dose, with dose frequency the only variable, patients randomised to one of three arms; One drop once daily; one drop twice daily; or one drop three times daily into study eye/s

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)