A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma
1 other identifier
observational
63
1 country
16
Brief Summary
The purpose of this observational research study is to follow participants who have been treated with bel-sar while participating in a previous Aura Biosciences clinical research study to assess the long-term safety and effectiveness in these subjects. The study will collect information based on assessments performed as part of the standard of care (SoC) for subjects with IL/CM, inclusive of all adverse events, concomitant medications and/or procedures, information regarding metastatic disease and details of treatments administered, and information about melanoma-related and all-cause mortality and cause of death (if applicable).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2019
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 27, 2019
CompletedFirst Submitted
Initial submission to the registry
May 3, 2019
CompletedFirst Posted
Study publicly available on registry
May 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
May 22, 2026
May 1, 2026
9.7 years
May 3, 2019
May 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Adverse Events and Serious Adverse Events that are related to IL/CM treatment with bel-sar.
5 years
Study Arms (1)
Subjects previously participated in an Aura Biosciences bel-sar study
Subjects with Choroidal Melanoma or Indeterminate Lesions.
Eligibility Criteria
Subjects with primary Indeterminate Lesions or Choroidal Melanoma who participated in previous Aura Biosciences sponsored clinical trial.
You may qualify if:
- 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 treatment in a previous Aura Biosciences sponsored clinical trial.
- Have completed the exit visit of the previous Aura Biosciences sponsored clinical trial within 1 year of Day 1 (≤365 days) of enrollment into the Registry.
You may not qualify if:
- \- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aura Bioscienceslead
Study Sites (16)
Retina Associates SW, P.C.
Tucson, Arizona, 85710, United States
UCLA Jules Stein Eye Institute
Los Angeles, California, 90095, United States
Byers Eye Institute at Stanford University
Palo Alto, California, 94303, United States
Retina Consultants of Sacramento
Sacramento, California, 95825, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114, United States
W. K. Kellogg Eye Center, University of Michigan
Ann Arbor, Michigan, 48105, United States
Associated Retinal Consultants, PC
Royal Oak, Michigan, 48073, United States
Retina Center
Minneapolis, Minnesota, 55404, United States
Columbia University Medical Center
New York, New York, 10032, United States
Oregon Health & Science University Casey Eye Institute
Portland, Oregon, 97239, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107, United States
Retina Consultants of Carolina, PA
Greenville, South Carolina, 29605, United States
St. Thomas Health / Tennessee Retina, PC
Nashville, Tennessee, 37203, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Retina Consultants of Houston
Houston, Texas, 77030, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Aura Biosciences Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2019
First Posted
May 7, 2019
Study Start
March 27, 2019
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2029
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share