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

Aura Biosciences

Status: Terminated

Conditions: Indeterminate Lesions; Choroidal Melanoma

Treatments: Drug: AU-011; Other: Standard of Care

Study type: Observational

Funder types: Industry

Identifiers

NCT05266430

AU-011-402

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

2 participants in 2 patient groups

Case Group

Description:

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

Treatment:

Drug: AU-011

Control Group

Description:

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

Treatment:

Other: Standard of Care