Could a daily eye gel replace injections for wet AMD?
NCT ID NCT07766473
First seen Aug 14, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
This trial is testing an experimental eye gel called BETA-TT8 for people with wet age-related macular degeneration (AMD), a condition that causes rapid vision loss. The gel is applied to the eye up to three times daily for 12 weeks, and standard injections remain available if needed. The study aims to see if the gel is safe and tolerable, and whether it might help control the disease. Around 24 adults with stable wet AMD who have already had at least three anti-VEGF injections will participate.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BETA-TT8 ophthalmic gel 3.8%
- What this could lead to
- If successful, this eye gel could offer a less invasive treatment option for wet AMD, potentially reducing the need for frequent eye injections.
- What could go wrong
- This is an early, first-in-human study with a small number of participants, so safety and effectiveness are not yet established. Possible risks include eye irritation, corneal issues, or increased eye pressure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Locations
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Central Coast Eye Specialist
Gosford, New South Wales, 2250, Australia
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Cerulea Clinical Trials
East Melbourne, Victoria, 3002, Australia
Contact Email: •••••@•••••
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Sydney Eye Hospital
Sydney, New South Wales, 2000, Australia
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Sydney West Retina
Westmead, New South Wales, 2145, Australia
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Other studies related to the condition(s) this trial covers.
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- New eye injection could reduce treatment frequency for wet AMD
- New study aims to keep macular disease patients on track with eye injections
- New eye injection could mean fewer doctor visits for wet AMD patients
- New syringe for eye disease injections passes usability test