A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011)
Treatment Compared to Sham Control in Patients with Primary Indeterminate Lesions or Small Choroidal Melanoma. Bel-sar is an investigational treatment for choroidal melanoma. It is an in-office procedure that involves the injection of bel-sar into the eye and activation by a laser.
Some of the Key Inclusion Criteria Include:
- Diagnosis of primary indeterminate tumor or small choroidal
melanoma - Have no evidence of metastatic disease confirmed by imaging
- Have not received treatment for choroidal melanoma (patients who received photodynamic therapy may be eligible)
Some of the Key Exclusion Criteria Include:
- Have known contraindications or sensitivities to the study drug or laser
- Active ocular infection or disease
Sites open to date:
- There will be approximately 70 sites open globally, approximately 35 in the US and 35 in Europe and Asia
- Patient participation may last up to 104 weeks:
- 4-week screening period
- 10-week study treatment
- 94-week follow-up period
- You may be reimbursed for travel expenses if receipt of expenses is provided.
- If you are eligible for the study and decide to participate, you will receive a stipend per visit for your time.
- Talk to your doctor about the trial and if you may be eligible to participate.
search “NCT06007690* on clinicaltrials.gov for more info
The Company also announced the presentation of positive Phase 2 safety and efficacy data of bel-sar with 90% of patients at twelve months of follow-up evaluating two key clinical endpoints: tumor control and visual acuity preservation using suprachoroidal (SC) route of administration for the first-line treatment of adult patients with early-stage CM. The results were presented at the American Academy of Ophthalmology (AAO) 2023 Annual Meeting in San Francisco, California.