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NCT03941379 Clinical Trial

A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma

Choroidal Melanoma Clinical Trial

Official title:
A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03941379
Other study ID # Registry AU-011-401
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 27, 2019
Est. completion date December 2029

Study information
Verified date December 2023
Source Aura Biosciences
Contact Medical Monitor
Phone 617-500-8864
Email clinical@aurabiosciences.com
Is FDA regulated No
Health authority
Study type Observational

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 2029
Est. primary completion date December 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Have been clinically diagnosed with primary IL or CM at the time of entry to a previous Aura Biosciences sponsored clinical trial. - Have received AU-011 bel-sar or assigned to a different cohort or treatment arm (sham, SoC, etc.) an observation cohort in a previous Aura sponsored clinical trial. Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States W. K. Kellogg Eye Center, University of Michigan Ann Arbor Michigan
United States Massachusetts Eye and Ear Infirmary Boston Massachusetts
United States Texas Retina Associates Dallas Texas
United States Retina Consultants of Carolina, PA Greenville South Carolina
United States Retina Consultants of Houston Houston Texas
United States UCLA Jules Stein Eye Institute Los Angeles California
United States University of Wisconsin Madison Wisconsin
United States Retina Center Minneapolis Minnesota
United States St. Thomas Health / Tennessee Retina, PC Nashville Tennessee
United States Columbia University Medical Center New York New York
United States Byers Eye Institute at Stanford University Palo Alto California
United States Wills Eye Hospital Philadelphia Pennsylvania
United States Oregon Health & Science University Casey Eye Institute Portland Oregon
United States Associated Retinal Consultants, PC Royal Oak Michigan
United States Retina Consultants of Sacramento Sacramento California
United States Retina Associates SW, P.C. Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
Aura Biosciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events and Serious Adverse Events that are related to IL/CM treatment with bel-sar, sham, SoC or alternative treatment. 5 years
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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)

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