Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

Trial ID or NCT#

NCT04417530

Status

recruiting iconRECRUITING

Purpose

The primary objective is to assess safety and efficacy of AU-011 via suprachoroidal injection to treat primary indeterminate lesions and small choroidal melanoma.

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - Have known contraindications or sensitivities to the study drug or laser - Active ocular disease
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Investigator(s)

Prithvi Mruthyunjaya, MD, MHS
Prithvi Mruthyunjaya, MD, MHS
Ophthalmologist
Professor of Ophthalmology and, by courtesy, of Radiation Oncology

Contact us to find out if this trial is right for you.

CONTACT

Mariana Nunez
(650) 723-6995

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View on ClinicalTrials.gov