Phase 2 study for people with Macular Degeneration
Not yet recruiting Phase 2
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Central Coast Eye Specialist | Gosford | NSW | Status not stated |
| Sydney Eye Hospital | Sydney | NSW | Status not stated |
| Sydney West Retina | Westmead | NSW | Status not stated |
| Cerulea Clinical Trials | East Melbourne | VIC | Status not stated |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
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.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 18 September 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.