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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-14

Study Completion Date

2023-04-20

Brief Summary

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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.

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Detailed Description

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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

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Choroidal Melanoma Indeterminate Lesions

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

AU-011

Intervention Type DRUG

Previously received

Control Group

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

Standard of Care

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

AU-011

Previously received

Intervention Type DRUG

Other Intervention Names

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belzupacap sarotalocan bel-sar

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No