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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05266430
Recruitment Status : Terminated (Sponsor Decision - Low Enrollment)
First Posted : March 4, 2022
Last Update Posted : August 9, 2023
Sponsor:
Information provided by (Responsible Party):
Aura Biosciences

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Choroidal Melanoma Indeterminate Lesions Other: Standard of Care Drug: AU-011

Detailed 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.
Study Design
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Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: 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)
Actual Study Start Date : April 14, 2022
Actual Primary Completion Date : February 1, 2023
Actual Study Completion Date : April 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
 Drug: AU-011
Previously received
Other Names:
  • belzupacap sarotalocan
  • bel-sar
Control Group
Patients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the investigator
 Other: 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


Outcome Measures
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Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: 5 years ]
    Change from baseline in logMAR visual acuity score at 5 years.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary Choroidal Melanoma and Indeterminate Lesions who are planned to receive plaque radiotherapy (Control Group) and subjects with primary Choroidal Melanoma and Indeterminate Lesions who participated in previous Aura Biosciences sponsored clinical trial. (Case Group)
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05266430


Locations
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United States, Michigan
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, United States, 48073
United States, Oregon
Oregon Health & Science University Casey Eye Institute
Portland, Oregon, United States, 97239
United States, South Carolina
Retina Consultants of Carolina, PA
Greenville, South Carolina, United States, 29605
United States, Tennessee
St. Thomas Health/Tennessee Retina, P.C.
Nashville, Tennessee, United States, 37203
United States, Texas
Retina Consultants of Texas
Bellaire, Texas, United States, 77401
Texas Retina Associates
Dallas, Texas, United States, 75231
United States, Wisconsin
University of Wisconsin Dept of Ophthalmology & Visual Sciences
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Aura Biosciences
Investigators
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Study Director: Medical Monitor Aura Biosciences, Inc.
More Information
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Additional Information:

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Responsible Party: Aura Biosciences
ClinicalTrials.gov Identifier: NCT05266430    
Other Study ID Numbers: AU-011-402
First Posted: March 4, 2022    Key Record Dates
Last Update Posted: August 9, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aura Biosciences:
AU-011
Belzupacap sarotalocan
Choroidal melanoma
Plaque radiotherapy
 Matched case control
Visual acuity
bel-sar
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas