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NCT05266430 Clinical Trial

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

Choroidal Melanoma Clinical Trial

— IL  

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)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT05266430
Other study ID # AU-011-402
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date April 14, 2022
Est. completion date April 20, 2023

Study information
Verified date August 2023
Source Aura Biosciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date April 20, 2023
Est. primary completion date February 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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
Drug:
• AU-011
Previously received

Locations
Country Name City State
United States Retina Consultants of Texas Bellaire Texas
United States Texas Retina Associates Dallas Texas
United States Retina Consultants of Carolina, PA Greenville South Carolina
United States University of Wisconsin Dept of Ophthalmology & Visual Sciences Madison Wisconsin
United States St. Thomas Health/Tennessee Retina, P.C. Nashville Tennessee
United States Oregon Health & Science University Casey Eye Institute Portland Oregon
United States Associated Retinal Consultants, P.C. Royal Oak Michigan

Sponsors (1)
Lead Sponsor Collaborator
Aura Biosciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Acuity Change from baseline in logMAR visual acuity score at 5 years. 5 years
See also
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Recruiting NCT03941379 - A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma
Completed NCT02875652 - Circulating Tumoral DNA in Choroidal Melanoma (ctDNA MU) N/A
Completed NCT00765921 - Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma Phase 1
Completed NCT00351728 - Combined PET/CT Imaging for the Early Detection of Ocular Melanoma Metastasis Compared to CT Scanning Alone N/A
Completed NCT01460810 - Safety and Efficacy of Silicone Oil Tamponade for Surgical Attenuation of Radiation Damage in Choroidal Melanoma N/A
Completed NCT01251978 - Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2) Phase 2
Completed NCT00344799 - Cytogenetic Study of Ocular Melanoma
Completed NCT01253759 - Long Term Results of Combined Transpupillary Thermotherapy (TTT) Indocyanine Green (ICG) Based Photodynamic Therapy (PDT) in Choroidal Melanoma Phase 4
Completed NCT03052127 - Study in Subjects With Small Primary Choroidal Melanoma Phase 1/Phase 2
Active, not recruiting NCT00111046 - Pain Relief - Tramadol Versus Ibuprofen Phase 1/Phase 2
Recruiting NCT06007690 - A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma Phase 3
Active, not recruiting NCT04417530 - Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma Phase 2

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