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Clinical Trial Summary

The purpose of this observational research study is to follow participants who have been treated with either bel-sar or received alternate treatment (sham, standard of care therapy, etc.) while participating in a previous Aura Biosciences clinical research study to assess the long-term safety and effectiveness in these subjects. This study will collect information from procedures conducted as part of routine follow-up eye care and cancer care. Additionally, the registry will collect all adverse events, information about pregnancy and symptomatic overdose.


Clinical Trial Description

This is a multi-center long-term observational Registry of subjects with Primary Indeterminate Lesions or Choroidal Melanoma. The Registry will initially be open to subjects who have previously participated in an Aura Biosciences bel-sar sponsored clinical trial for their primary Choroidal Melanoma or Indeterminate Lesions. All subjects will be followed for a minimum of 5 years (including time enrolled in an Aura sponsored clinical trial), until withdrawal of consent, or until death whichever comes first. No interventions will be required as part of the Registry. Data collection will be based on IL or CM information anticipated to be available based on the standard of care for subjects with CM or IL. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03941379
Study type Observational
Source Aura Biosciences
Contact Medical Monitor
Phone 617-500-8864
Email clinical@aurabiosciences.com
Status Recruiting
Phase
Start date March 27, 2019
Completion date December 2029

See also
  Status Clinical Trial Phase
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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
Terminated NCT05266430 - Prospective Group-Matched Study With Belzupacap Sarotalocan (Bel-sar; AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)