Prospective Group-Matched Study With Belzupacap Sarotalocan (Bel-sar; AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM) (IL)

August 7, 2023 updated by: Aura Biosciences

A Prospective Group-Matched Study of Visual Outcomes in Subjects Treated With Belzupacap Sarotalocan (AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)

This is a prospective multicenter, group-matched study of patients with primary indeterminate lesions or choroidal melanoma who receive treatment with belzupacap sarotalocan (bel-sar; AU-011) and patients who are planned to receive standard of care (SOC) treatment with plaque radiotherapy (plaque) to compare the visual outcomes of AU-011 and plaque radiotherapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Up to approximately 45 patients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the Investigator are planned to be enrolled.

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Associated Retinal Consultants, P.C.
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University Casey Eye Institute
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Retina Consultants of Carolina, PA
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • St. Thomas Health/Tennessee Retina, P.C.
    • Texas
      • Bellaire, Texas, United States, 77401
        • Retina Consultants of Texas
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin Dept of Ophthalmology & Visual Sciences

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with primary Choroidal Melanoma and Indeterminate Lesions who are planned to receive plaque radiotherapy (Control Group) and subjects with primary Choroidal Melanoma and Indeterminate Lesions who participated in previous Aura Biosciences sponsored clinical trial. (Case Group)

Description

Have per the investigator's expert clinical judgment, a clinical diagnosis of primary indeterminate lesion or choroidal melanoma based on the clinical history, ophthalmic examination, fundus photography and conventional ocular ultrasound.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Group
Patients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the investigator
Other: Standard of Care
Patients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the investigator
Case Group
Patients with primary Choroidal Melanoma and Indeterminate Lesions who have received belzupacap sarotalocan (bel-sar; AU-011) in a previous Aura sponsored clinical trial
Drug: AU-011
Previously received
Other Names:
  • belzupacap sarotalocan
  • bel-sar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: 5 years
Change from baseline in logMAR visual acuity score at 5 years.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aura Biosciences

Investigators

  • Study Director: Medical Monitor, Aura Biosciences, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

April 14, 2022

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

April 20, 2023

Study Registration Dates

First Submitted

February 23, 2022

First Submitted That Met QC Criteria

March 3, 2022

First Posted (Actual)

March 4, 2022

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU-011-402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Choroidal Melanoma

Clinical Trials on AU-011

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe