A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma
1 other identifier
observational
500
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ 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, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
December 21, 2023
December 1, 2023
10.7 years
May 3, 2019
December 20, 2023
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, sham, SoC or alternative treatment.
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 or assigned to a different cohort or treatment arm (sham, SoC, etc.) an observation cohort in a previous Aura sponsored clinical trial.
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.
Central Study Contacts
Medical Monitor
CONTACT
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, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
December 21, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share