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Clinical trial

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)

ID
Name
AU-011-402
Description
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.
Trial arms
Trial start
2022-04-14
Estimated PCD
2023-02-01
Trial end
2023-04-20
Status
Terminated
Treatment
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
Arms:
Control Group
AU-011
Previously received
Arms:
Case Group
Other names:
belzupacap sarotalocan, bel-sar
Size
2
Primary endpoint
Visual Acuity
5 years
Eligibility 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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 2, 'type': 'ACTUAL'}}
Updated at
2023-08-09

1 organization

1 product

2 indications

Product
AU-011
Indication
Choroidal Melanoma
Indication
Indeterminate Lesions
Organization
Aura Biosciences