RECRUITING

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

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Conditions

Choroidal MelanomaIndeterminate LesionsUveal MelanomaOcular MelanomaEye Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2023-12-06
Study Completion:2027-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06007690

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
  2. * Have no evidence of metastatic disease confirmed by imaging
  3. * Be treatment naive for IL/CM (subjects who received PDT may be eligible)
  1. * Have known contraindications or sensitivities to the study drug or laser
  2. * Active ocular infection or disease

Contacts and Locations

Study Contact

Medical Monitor
CONTACT
617-500-8864
clinical@aurabiosciences.com

Principal Investigator

Medical Monitor
STUDY_DIRECTOR
Aura Biosciences

Study Locations (Sites)

Retina Consultants of Alabama
Birmingham, Alabama, 35233
United States
UCSD Shiley Eye Institute, Jacobs Retina Center
La Jolla, California, 92093
United States
Doris Stein Eye Research Center
Los Angeles, California, 90095
United States
Stanford University School of Medicine
Palo Alto, California, 94303
United States
Retinal Consultants Medical Group, Inc.
Sacramento, California, 95825
United States
UCSF Ocular Oncology Clinic
San Francisco, California, 94143
United States
Colorado Retina Associates
Lakewood, Colorado, 80228
United States
Bascom Palmer Eye Institute
Miami, Florida, 33136
United States
Retina Associates of Florida, PA
Tampa, Florida, 33609
United States
Emory Eye Center
Atlanta, Georgia, 30322
United States
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Tufts Medical Center New England Eye Center
Boston, Massachusetts, 02111
United States
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
United States
W.K. Kellogg Eye Center - University of Michigan
Ann Arbor, Michigan, 48105
United States
Associated Retinal Consultants (ARC) P.C.
Royal Oak, Michigan, 48073
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Washington University
Saint Louis, Missouri, 63110
United States
Nebraska Medicine's Truhlsen Eye Institute
Omaha, Nebraska, 68105
United States
New Jersey Retina Group
Wayne, New Jersey, 07470
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
University of Rochester, Flaum Eye Institute
Rochester, New York, 14642
United States
Duke Eye Center
Durham, North Carolina, 27705
United States
Cole Eye Institute
Cleveland, Ohio, 44195
United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104
United States
Shields & Shields PC-Wills Eye Institute
Philadelphia, Pennsylvania, 19107
United States
Retina Consultants of Carolina
Greenville, South Carolina, 29605
United States
Southeastern Retina Associates
Chattanooga, Tennessee, 37421
United States
Tennessee Retina, PC
Nashville, Tennessee, 37203
United States
Austin Retina Associates
Austin, Texas, 78705
United States
Texas Retina Associates
Dallas, Texas, 75231
United States
UT, Southwestern Medical Center
Dallas, Texas, 75390
United States
Retina Associates of South Texas, P.A.
San Antonio, Texas, 78240
United States
Retina Center of Texas
Southlake, Texas, 76092
United States
Retina Consultants of Texas
The Woodlands, Texas, 77401
United States
Retina Associates of Utah
Salt Lake City, Utah, 84107
United States
Moran Eye Center University of Utah
Salt Lake City, Utah, 84132
United States
Vitreoretinal Associates of Washington
Bellevue, Washington, 98004
United States
University of Washington Medical Center
Seattle, Washington, 98104
United States
University of Wisconsin Madison
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: Aura Biosciences

  • Medical Monitor, STUDY_DIRECTOR, Aura Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-06
Study Completion Date2027-03-01

Study Record Updates

Study Start Date2023-12-06
Study Completion Date2027-03-01

Terms related to this study

Keywords Provided by Researchers

  • Uveal Melanoma
  • Eye Cancer
  • Ocular Melanoma
  • Choroidal Melanoma

Additional Relevant MeSH Terms

  • Choroidal Melanoma
  • Indeterminate Lesions
  • Uveal Melanoma
  • Ocular Melanoma