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

NCT05266430 | Terminated FDA Drug

• 1 other identifier: AU-011-402
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Choroidal Melanoma; Indeterminate Lesions

Keywords

AU-011; Belzupacap sarotalocan; Choroidal melanoma; Plaque radiotherapy; Matched case control; Visual acuity; bel-sar

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  Change from baseline in logMAR visual acuity score at 5 years.

  5 years

Study Arms (2)

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

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

Interventions

Standard of Care OTHER

Patients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the investigator

Control Group

AU-011 DRUG

Previously received

Also known as: belzupacap sarotalocan, bel-sar

Case Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Aura Biosciences: lead

Study Sites (7)

Associated Retinal Consultants, P.C.

Royal Oak, Michigan, 48073, United States

Location

Oregon Health & Science University Casey Eye Institute

Portland, Oregon, 97239, United States

Location

Retina Consultants of Carolina, PA

Greenville, South Carolina, 29605, United States

Location

St. Thomas Health/Tennessee Retina, P.C.

Nashville, Tennessee, 37203, United States

Location

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

University of Wisconsin Dept of Ophthalmology & Visual Sciences

Madison, Wisconsin, 53705, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Medical Monitor

  Aura Biosciences, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 4, 2022
• Study Start: April 14, 2022
• Primary Completion: February 1, 2023
• Study Completion: April 20, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)