A Phase 1/2 interventional study of BETA-TT8 ophthalmic gel 3.8% w/v in Neovascular (Wet) Age-Related Macular Degeneration, sponsored by Filamon LTD. Not yet recruiting at 4 sites in Australia. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Filamon LTD · Phase 1/2, Interventional, and Treatment
Among 77 studies in Macular Degeneration with a site in Australia — 17 open to participants now, 22 under way, 7 of them phase 3. Macular Degeneration · Australia.
Among the 77 studies in Macular Degeneration with a site in Australia, this one is the 60th largest by planned enrollment of the 66 interventional ones that give a count, is one of 5 that started in 2026, is one of 6 in phase 1/2, reaches primary completion later than 4 of the 21 other live ones, and was the 77th registered.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
Browse Macular Degeneration studies →17 of the 77 studies in Macular Degeneration with a site in Australia are open now. Recruiting first, the newest first:
Biojiva LLC · Sites in Australia, United States
Ages 55+
Sitala Bio LTD · Sites in Australia, United States, Argentina and 4 more countries
Ages 60+
EyeBiotech Ltd. · Sites in Australia, United States, Argentina and 9 more countries
Ages 50+
Novartis Pharmaceuticals · Sites in Australia, United States, Argentina and 16 more countries
Ages 50+
ADARx Pharmaceuticals, Inc. · Sites in Australia, United States, Austria and 9 more countries
Ages 60+
A study can be open while its sites in Australia have not opened yet or have stopped. Only those recruiting at a site in Australia →
Of the 166 Macular Degeneration studies recruiting now, 117 (70%) set no upper age limit and 5 (3%) stop at 75 or younger; 19 take children under 18; 35 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
77 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 26 · Phase 3 26 · Phase 4 6
First in 2003; this study’s year is marked. 5 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 24 is below the median of 56 across 985 interventional studies indexed under Macular Degeneration.
Median enrollment 280 across the 66 interventional studies, 400 across the 11 observational. Of the 54 that completed or were terminated, 30 (56%) have results posted.
This tab as a report to print or save as PDF → With an account.
67 of 77 have an industry lead sponsor. The 10 most frequent:
Filamon LTD is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Filamon LTD has 1 study filed under Macular Degeneration — fewer than ten, so there is no comparison to draw.
9 of the studies in Macular Degeneration with a site in Australia that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06495918Phase 3Ocular Therapeutix, Inc.Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration | 2027-01-08 |
| NCT04657289Phase 3Hoffmann-La RocheA Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome) | 2027-02-04 |
| NCT07064759Phase 34D Molecular TherapeuticsSingle Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration | 2027-11 |
| NCT05803785Benobio Co., Ltd.Safety of BBC1501 Intravitreal Injection in Patients With Neovascular Age-Related Macular Degeneration (nAMD) | 2026-12 |
| NCT07766473Filamon LTDFirst in Human Study of BETA-TT8 in wetAge-related Macular Degeneration (wetAMD) | 2027-03 |
Add all 9 to your calendar (.ics) → With an account.
Among the 77 studies in Macular Degeneration with a site in Australia, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Ocular Exclusion Criteria
Systemic Exclusion Criteria
Other Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One drop, once daily
Drug: BETA-TT8 ophthalmic gel 3.8% w/v
One drop, twice daily
Drug: BETA-TT8 ophthalmic gel 3.8% w/v
One drop, three times daily
Drug: BETA-TT8 ophthalmic gel 3.8% w/v
A selective small-molecule inhibitor of the MEK/ERK (MAPK) signalling pathway, topical ophthalmic gel.
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
To evaluate the tolerability of topical BETA-TT8 based on reasons for discontinuations.
Incidence of treatment discontinuations due to adverse events.
Time frame: 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.
Time frame: 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.
Time frame: 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 Central Subfield Thickness (CST) at each scheduled visit.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
To assess systemic exposure effects of BETA-TT8 over the Extension Phase
Systemic exposure effects will be captured through fellow-eye (i.e. non-treated eye) safety assessments measuring mean change in BVCA (ETDRS letters) from baseline to each scheduled visit.
Time frame: 12 months
To assesses potential efficacy of BETA-TT8 over the Extension Phase
At each scheduled visit during the Extension Phase, BCVA (ETDRS letters) assessment will be performed measuring mean change from baseline to each scheduled visit as previously described.
Time frame: 12 months
To characterise aflibercept injection burden over the 12-month Extension Phase
This will be done by recording the cumulative number of rescues (aflibercept injection) required over the Extension Phase, compared to site-derived historical anti-VEGF standards.
Time frame: 12 months
To assesses potential efficacy of BETA-TT8 over the Extension Phase
At each scheduled visit during the Extension Phase, CST assessments will be performed as previously described.
Time frame: 12 months
To assesses potential efficacy of BETA-TT8 over the Extension Phase
At each scheduled visit during the Extension Phase, intraretinal fluid/sub-retinal fluid (IRF/SRF) assessments will be performed as previously described.
Time frame: 12 months
To assesses potential efficacy of BETA-TT8 over the Extension Phase
Patient reported outcomes will also be assessed at time points using the NEI-VFQ-25 questionnaire (National Eye Institute Visual Function Questionnaire-25).
Time frame: 12 months
To assess systemic exposure effects of BETA-TT8 over the Extension Phase
Systemic exposure effects will be captured through fellow-eye (i.e. non-treated eye) safety assessment, measuring mean change in CST from baseline to each scheduled visit.
Time frame: 12 months
To assess systemic exposure effects of BETA-TT8 over the Extension Phase
Systemic exposure effects will be captured through fellow-eye (i.e. non-treated eye) safety assessments measuring mean change in slit-lamp from baseline to each scheduled visit.
Time frame: 12 Months
To assess systemic exposure effects of BETA-TT8 over the Extension Phase
Systemic exposure effects will be captured through sparse plasma BETA-TT8 concentration at specified scheduled visits.
Time frame: 12 months
Plan to share: No — IPD will not be shared due to commercial in confidence restrictions.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.
Of 52 phase 1/2 interventional studies under Macular Degeneration, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Filamon LTD