A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects with Primary Indeterminate Lesions or Small Choroidal Melanoma
Study Status: Enrolling
What is the purpose of this study?
This is a randomized, sham-controlled, subject-, assessor-, and sponsor-masked trial to establish the efficacy and safety of belzupacap sarotalocan treatment via SC administration in subjects with primary IL/CM.
What will I have to do if I take part in this study?
The planned duration of subject participation in this trial will be approximately 24 months (104 weeks) after randomization to a trial treatment. If you are eligible and want to be part of the study, you will participate for 3-4 months with the treatment (up to 19 – 20 study visits), and follow-up for 18-20 months (up to 9 study visits). The researchers will ask you to do the following: Answer some questionnaires, have your visual acuity and visual fields tested, have anterior and posterior of your eyes examined, have photographs taken of the back of your eyes. You will receive suprachoroidal (SC) administration with belzupacap sarotalocan following by laser treatment in clinic. All of these procedures will be paid for by the study.
Is this the right trial for me?
If you are over the age of 18 years and have no evidence of metastatic disease confirmed per the standard of care (SOC) treatments and have per the iInvestigator’s expert clinical judgment to meet the criteria of this trial.
For additional information:
- Principal Investigator: Hans E Grossniklaus, MD
- Trial Coordinator: Ying Li
- ClinicalTrials.gov: NCT06007690 Study Record | ClinicalTrials.gov