Neovascular (Wet) Age-Related Macular DegenerationPhase 1/2BEyONDNCT07766473
First in Human Study of BETA-TT8 in wetAge-related Macular Degeneration (wetAMD)
A Phase 1/2 study testing BETA-TT8 ophthalmic gel 3.8% w/v in people with Neovascular (Wet) Age-Related Macular Degeneration, run by Filamon LTD at 4 sites in Australia.
Trial 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)… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular (Wet) Age-Related Macular Degeneration
- What is being tested?
- BETA-TT8 ophthalmic gel 3.8% w/v
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 4 sitesAustralia
- Study dates
- Sep 2026to Sep 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia4 sites
Cerulea Clinical Trials
East Melbourne, Victoria, 3002
Sanjeewa Wickremasinghe, 03 9959 0057, info@ceruleaclinicaltrials.org.au
Jennifer Hollands, 03 9959 0057, jhollands@cerulea.org.au
Central Coast Eye Specialist
Gosford, New South Wales, 2250
Hemal Mehta, MBBS MD, FRCOphth FRANZCO, (02) 4325 2482, HM@ispecialist.org
Sarrvesa Singh, (02) 4325 2482, sarrvesa.singh@retinaclinicaltrials.com.au
Sydney Eye Hospital
Sydney, New South Wales, 2000
Samantha Fraser Bell, 02 9382 7309, lamda.seh.coordinator@groups.syndey.edu.au
Maria Williams, +61 02 9382 7309, lamda.seh.coordinator@groups.sydney.edu.au
Sydney West Retina
Westmead, New South Wales, 2145
Paul Mitchell, MBBS (hons) MD PhD FRANZCO, 02 9893 9022, paul.mitchell@sydney.edu.au
Honey Grace Paule, 02 9893 9022, honeygrace.swr@gmail.com
About this study
Official title: 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.
Read the detailed description
This is a Phase Ib/IIa, first-in-human, open-label, multi-centre study of BETA-TT8 Ophthalmic Gel 3.8% in patients with neovascular (wet) age-related macular degeneration. BETA-TT8 is administered topically to the study eye. The study enrols twenty-four (24) patients recently diagnosed with wetAMD and stable on standard-of-care anti-VEGF at entry (stable being defined as absence of intraretinal fluid, less than 200microns of subretinal fluid, no new macula haemorrhage and stable visual acuity-less than 5 Early Treatment Diabetic Retinopathy Study (ETDRS) letter difference- over the last two visits), in three parallel groups of eight (8) per group. BETA-TT8 is added to each patient's established anti-VEGF backbone at a single fixed dose, identical across all three groups. Patients first receive a minimum of three loading intravitreal aflibercept 2 mg injections per the approved label. BETA-TT8 is then introduced approximately one week after the third or more injections. Aflibercept remains available as rescue throughout; BETA-TT8 dosing continues during and after rescue. All patients are randomised to one of three groups for the 12-week period (Group 1: Once-daily (OD); Group 2: Twice-daily (BD); Group 3: Three-times-daily (TDS)). Dose per administration is identical throughout and across groups; dosing frequency is the only variable. This is a safety and tolerability evaluation; dosing-frequency-finding is a pre-specified exploratory aim. Participants meeting the pre-specified Extension Gate criteria at Week 12 may enter a 12-month open-label extension.
- Being tested
- BETA-TT8 ophthalmic gel 3.8% w/v
- Keywords
- BETA-TT8, wetAMD, Ophthalmic gel, neovascular AMD, ophthalmology
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BETA-TT8 ophthalmic gel 3.8% w/vDrug
A selective small-molecule inhibitor of the MEK/ERK (MAPK) signalling pathway, topical ophthalmic gel.
| Study group | Role | What they receive |
|---|---|---|
| BETA-TT8 Ophthalmic topical gel - Group one | Active comparator | One drop, once daily Receives: Drug: BETA-TT8 ophthalmic gel 3.8% w/v |
| BETA-TT8 Ophthalmic topical gel - Group two | Active comparator | One drop, twice daily Receives: Drug: BETA-TT8 ophthalmic gel 3.8% w/v |
| BETA-TT8 Ophthalmic topical gel - Group three | Active comparator | One drop, three times daily Receives: Drug: BETA-TT8 ophthalmic gel 3.8% w/v |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
To evaluate the tolerability of topical BETA-TT8 based on reasons for discontinuations.
Incidence of treatment discontinuations due to adverse events.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (5)
To further characterise ocular safety following repeated topical administration based on preliminary biological activity data.
Based on Optical Coherence Tomography (OCT)-derived anatomical measures, including:
- Mean change from baseline in Central Subfield Thickness (CST) at each scheduled visit.
Measured: 12 weeks
Exploratory-efficacy signals during BETA-TT8 treatment phase.
Exploratory efficacy signals, if identified, will inform endpoint selection and sample size determination for future adequately powered studies.
- Time to first Aflibercept rescue (Kaplan-Meier) , referenced descriptively against site-derived historical anti-VEGF injection-burden data.
Measured: 12 weeks
Exploratory-efficacy signals during BETA-TT8 treatment phase.
Exploratory efficacy signals, if identified, will inform endpoint selection and sample size determination for future adequately powered studies.
- Number of Aflibercept rescue injections during the 12-week treatment phase, referenced descriptively against site-derived historical anti-VEGF injection-burden data.
Measured: 12 weeks
Exploratory-efficacy signals during BETA-TT8 treatment phase.
Exploratory efficacy signals, if identified, will inform endpoint selection and sample size determination for future adequately powered studies.
- Within-patient change in anti-VEGF rescue interval relative to each patient's own documented pre-study injection interval.
Measured: 12 weeks
To further characterise ocular safety following repeated topical administration based on preliminary biological activity data.
Based on Optical Coherence Tomography (OCT)-derived anatomical measures, including:
- Mean change from baseline in Best Corrected Visual Acuity (BCVA) at each scheduled visit.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular (Wet) Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Filamon LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hemal Mehta, MBBS MD, FRCOphth FRANZCO, Principal investigator, Central Coast Eye Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766473
- Sponsor's protocol ID
- BETA-TT8-001
- Acronym
- BEyOND
- Status last verified
- Sep 2026
- First submitted
- 21 Jul 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to commercial in confidence restrictions.