NCT05266430

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

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)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Aura Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Choroidal Melanoma
• Indeterminate Lesions

Interventions

Type	Name	Description
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
DRUG	AU-011	Previously received

Timeline

• Start date: 2022-04-14
• Primary completion: 2023-02-01
• Completion: 2023-04-20
• First posted: 2022-03-04
• Last updated: 2023-08-09

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study