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

Description

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).

Conditions

Choroidal Melanoma, Indeterminate Lesions, Uveal Melanoma, Ocular Melanoma

Study Overview

Study Details

Study overview

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).

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

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

Condition
Choroidal Melanoma
Intervention / Treatment

-

Contacts and Locations

Birmingham

Retina Consultants of Alabama, Birmingham, Alabama, United States, 35233

La Jolla

UCSD Shiley Eye Institute, Jacobs Retina Center, La Jolla, California, United States, 92093

Los Angeles

Doris Stein Eye Research Center, Los Angeles, California, United States, 90095

Palo Alto

Stanford University School of Medicine, Palo Alto, California, United States, 94303

Sacramento

Retinal Consultants Medical Group, Inc., Sacramento, California, United States, 95825

San Francisco

UCSF Ocular Oncology Clinic, San Francisco, California, United States, 94143

Lakewood

Colorado Retina Associates, Lakewood, Colorado, United States, 80228

Miami

Bascom Palmer Eye Institute, Miami, Florida, United States, 33136

Tampa

Retina Associates of Florida, PA, Tampa, Florida, United States, 33609

Atlanta

Emory Eye Center, Atlanta, Georgia, United States, 30322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Aura Biosciences,

Medical Monitor, STUDY_DIRECTOR, Aura Biosciences

Study Record Dates

2027-03-01