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

Contact:

NCT Number:

Protocol:

AAAV7661

Study Status:

Active/Enrolling

Population:

Adult

Phase:

III

The purpose of this study is to test and determine how safe and how well bel-sar treatment works compared to sham (no medication or laser) in participants who have a type of eye cancer called an indeterminate lesion (a growth in your eye that is suspected to be melanoma) or choroidal melanoma, also known as eye melanoma. We hope that Bel-sar can selectively target and destroy the tumor cells in the eye, while not affecting the normal cells. Bel-sar has not been approved by Food and Drug Administration (FDA).

Are you Eligible? (Inclusion Criteria)

  • must be 18 years old or older - must not have any active ocular infection or disease in the eye that may progress - must not have used an investigation drug or medical device within 30 days prior to enrolling to this study

Specialty Area(s)

Melanoma

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032