clinical trial · NCT06007690
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
Choroidal MelanomaIndeterminate LesionsUveal MelanomaOcular MelanomaBel-sarSuprachoroidal MicroinjectorInfrared LaserSham Infrared LaserSham Microinjector
brief summary
The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).
started
Dec 6, 2023
primary completion
Nov 15, 2027
completion
Aug 15, 2028
last updated
Mar 2, 2026
detailed description
This is a randomized, sham-controlled, subject-, assessor-, and Sponsor- masked trial to establish the safety and efficacy of bel-sar treatment via suprachoroidal (SC) administration in subjects with primary IL/CM. Bel-sar treatment incorporates administration of bel-sar drug product using a suprachoroidal space (SCS) microinjector and activation of bel-sar by a laser photoactivation device.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol