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

What this Trial Is About

Researchers are evaluating the safety and effectiveness of belzupacap sarotalocan bel-sar compared to a sham control in adults with primary indeterminate lesions or small choroidal melanoma. This phase 3 trial aims to establish whether bel-sar, administered via a specialized eye injection, can better manage these eye tumors. The study is carefully designed to keep participants and assessors unaware of the treatment given to ensure unbiased results. Participants receive either a high or low dose of bel-sar through a suprachoroidal microinjector followed by activation with an infrared laser, or they receive sham injections and sham laser treatments as a control. The treatment uses a special device to deliver the drug in the space around the eye, and the laser helps activate the drug. Three study groups are compared high dose bel-sar with laser, low dose bel-sar with laser, and sham procedures. During the trial, participants will be monitored for up to 65 weeks to assess tumor progression and other outcomes. Researchers will evaluate the time it takes for tumors to progress and other combined measures related to the disease. Safety and treatment effects will be closely observed throughout the study period. The study started in December 2023 and is expected to end in August 2028, with participants involved in scheduled assessments and monitoring visits.

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