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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

RECRUITINGPhase 3Sponsored by Aura Biosciences
Actively Recruiting
PhasePhase 3
SponsorAura Biosciences
Started2023-12-06
Est. completion2027-11-15
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations36 sites
View on ClinicalTrials.gov →

NCT06007690

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).

Eligibility

Age: 18 Years+Healthy volunteers accepted
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 naive for IL/CM (subjects who received PDT may be eligible)

Exclusion Criteria:

* Have known contraindications or sensitivities to the study drug or laser
* Active ocular infection or disease

Conditions5

CancerChoroidal MelanomaIndeterminate LesionsOcular MelanomaUveal Melanoma

Interventions1

Bel-sar

Locations36 sites

Retina Consultants of Alabama
Birmingham, Alabama, 35233
UCSD Shiley Eye Institute, Jacobs Retina Center
La Jolla, California, 92093
Doris Stein Eye Research Center
Los Angeles, California, 90095
Stanford University School of Medicine
Palo Alto, California, 94303
Retinal Consultants Medical Group, Inc.
Sacramento, California, 95825

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