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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)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Retina Consultants of Texas
Bellaire, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
University of Wisconsin Dept of Ophthalmology & Visual Sciences
Madison, Wisconsin, United States
Start Date
April 14, 2022
Primary Completion Date
February 1, 2023
Completion Date
April 20, 2023
Last Updated
August 9, 2023
2
ACTUAL participants
Standard of Care
OTHER
AU-011
DRUG
Lead Sponsor
Aura Biosciences
NCT06007690
NCT03941379
Data Source & Attribution
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