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

Terminated

• Conditions: Choroidal Melanoma; Indeterminate Lesions
• Interventions: Drug: AU-011; Other: Standard of Care

• Registration Number: NCT05266430
• Lead Sponsor: Aura Biosciences

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.

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 Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-04
• Study Start: 2022-04-14
• Primary Completion: 2023-02-01
• Study Completion: 2023-04-20
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case Group	AU-011	Patients with primary Choroidal Melanoma and Indeterminate Lesions who have received belzupacap sarotalocan (bel-sar; AU-011) in a previous Aura sponsored clinical trial
Control Group	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

Primary Outcome Measures

Name	Time	Method
Visual Acuity	5 years	Change from baseline in logMAR visual acuity score at 5 years.

Trial Locations

Locations (7)

University of Wisconsin Dept of Ophthalmology & Visual Sciences; 🇺🇸 Madison, Wisconsin, United States

Retina Consultants of Texas; 🇺🇸 Bellaire, Texas, United States

Oregon Health & Science University Casey Eye Institute; 🇺🇸 Portland, Oregon, United States

Retina Consultants of Carolina, PA; 🇺🇸 Greenville, South Carolina, United States

Associated Retinal Consultants, P.C.; 🇺🇸 Royal Oak, Michigan, United States

Texas Retina Associates; 🇺🇸 Dallas, Texas, United States

St. Thomas Health/Tennessee Retina, P.C.; 🇺🇸 Nashville, Tennessee, United States