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

Aura Biosciences2 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Choroidal Melanoma Indeterminate Lesions

Interventions

Standard of CareOTHER

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

AU-011DRUG

Previously received

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Associated Retinal Consultants, P.C.

Royal Oak, Michigan, United States

Oregon Health & Science University Casey Eye Institute

Portland, Oregon, United States

Retina Consultants of Carolina, PA

Greenville, South Carolina, United States

St. Thomas Health/Tennessee Retina, P.C.

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Visual Acuity

Change from baseline in logMAR visual acuity score at 5 years.

Time frame: 5 years

Data from ClinicalTrials.gov

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