Registry for patients with eye lesions or choroidal melanoma
A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma
This study is tracking patients who have been treated for eye lesions or choroidal melanoma to see how well the treatments work and if there are any long-term side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aura Biosciences Industry-sponsored |
| Locations | 16 sites (Tucson, Arizona and 15 other locations) |
| Trial ID | NCT03941379 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to follow participants who have been treated for primary indeterminate lesions or choroidal melanoma in previous clinical trials sponsored by Aura Biosciences. The study will collect long-term safety and effectiveness data based on routine follow-up care and will document any adverse events, pregnancy information, and symptomatic overdose. Participants will be monitored for a minimum of five years, with data collection relying on standard care practices for these conditions.
Who should consider this trial
Good fit: Ideal candidates are individuals who have previously participated in an Aura Biosciences clinical trial for choroidal melanoma or indeterminate lesions.
Not a fit: Patients who have not participated in prior Aura Biosciences clinical trials may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the long-term outcomes and safety of treatments for choroidal melanoma and indeterminate lesions.
How similar studies have performed: Other observational studies have shown success in tracking long-term outcomes for similar conditions, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tucson, Arizona and 15 other locations
- Retina Associates SW, P.C. — Tucson, Arizona, United States (Recruiting)
- UCLA Jules Stein Eye Institute — Los Angeles, California, United States (Recruiting)
- Byers Eye Institute at Stanford University — Palo Alto, California, United States (Recruiting)
- Retina Consultants of Sacramento — Sacramento, California, United States (Active_not_recruiting)
- Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States (Recruiting)
- W. K. Kellogg Eye Center, University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Associated Retinal Consultants, PC — Royal Oak, Michigan, United States (Recruiting)
- Retina Center — Minneapolis, Minnesota, United States (Recruiting)
- Columbia University Medical Center — New York, New York, United States (Recruiting)
- Oregon Health & Science University Casey Eye Institute — Portland, Oregon, United States (Recruiting)
- Wills Eye Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
- Retina Consultants of Carolina, PA — Greenville, South Carolina, United States (Recruiting)
- St. Thomas Health / Tennessee Retina, PC — Nashville, Tennessee, United States (Recruiting)
- Texas Retina Associates — Dallas, Texas, United States (Recruiting)
- Retina Consultants of Houston — Houston, Texas, United States (Recruiting)
- University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Medical Monitor
- Email: clinical@aurabiosciences.com
- Phone: 617-500-8864
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.