The primary objective is to determine the safety, tolerability, and preliminary efficacy of belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).
This is an open-label, ascending single and repeat dose escalation trial designed to evaluate the safety, tolerability, and preliminary efficacy of up to 4 dose levels and repeat dose regimens of belzupacap sarotalocan via suprachoroidal administration with 1 or 2 laser applications per treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Retina Associates SW, P.C.
Tucson, Arizona, United States
Treatment related AEs and treatment related serious adverse events (SAEs).
Adverse Events
Time frame: 52 weeks
Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.
Tumor Thickness Growth Rate
Time frame: 52 weeks
Time to reach tumor progression
Tumor progression
Time frame: 52 weeks
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