First in Human Study of BETA-TT8 in wetAge-related Macular Degeneration (wetAMD) (NCT07766473) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
First in Human Study of BETA-TT8 in wetAge-related Macular Degeneration (wetAMD)
Australia24 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Unco…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the safety of topical BETA-TT8 based on TEAEs.
Timeframe: 12 weeks
2
To evaluate the safety of topical BETA-TT8 based on DLTs.
Timeframe: 12 weeks
3
To evaluate the safety of topical BETA-TT8 based on clinically significant ocular findings.
Timeframe: 12 weeks
4
To evaluate the safety of topical BETA-TT8 based on intraocular pressure changes.
Timeframe: 12 weeks
5
To evaluate the safety of topical BETA-TT8 based on corneal staining abnormalities.
Timeframe: 12 weeks
6
To evaluate the tolerability of topical BETA-TT8 based on reasons for discontinuations.
Timeframe: 12 weeks
7
To evaluate the safety of topical BETA-TT8 based on TEAEs.