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Could a daily eye gel replace injections for wet AMD?

NCT ID NCT07766473

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

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

50 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    4 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Locations

  • Central Coast Eye Specialist

    Gosford, New South Wales, 2250, Australia

  • Cerulea Clinical Trials

    East Melbourne, Victoria, 3002, Australia

    Contact Email: •••••@•••••

  • Sydney Eye Hospital

    Sydney, New South Wales, 2000, Australia

  • Sydney West Retina

    Westmead, New South Wales, 2145, Australia

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