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Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
Not Recruiting
Trial ID: NCT04417530
Purpose
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).
Official Title
A Phase 2 Open-label, Ascending Single and Repeat Dose Escalation Trial of Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
Stanford Investigator(s)
Prithvi Mruthyunjaya, MD, MHS
Professor of Ophthalmology and, by courtesy, of Radiation Oncology
Eligibility
Inclusion Criteria:
- Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
- Have no evidence of metastatic disease confirmed by imaging
- Be treatment naïve for IL/CM
Exclusion Criteria:
- Have known contraindications or sensitivities to the study drug or laser
- Active ocular disease
Intervention(s):
drug: AU-011
device: Suprachoroidal Microinjector
device: PDT Laser
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mariana Nunez
650-723-6995