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A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma

NCT03941379 · Aura Biosciences
In plain English

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About this study
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.
Eligibility 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
Study design
Enrollment target: 500 participants
Age groups: adult, older_adult
Timeline
Starts: 2019-03-27
Estimated completion: 2029-12
Last updated: 2023-12-21
Primary outcomes
  • 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)
Sponsor
Aura Biosciences · industry
Contacts & investigators
ContactMedical Monitor · contact · clinical@aurabiosciences.com · 617-500-8864
ContactMedical Monitor · contact
InvestigatorMedical Monitor · study_director, Aura Biosciences Inc.
All locations (16)
Retina Associates SW, P.C.Recruiting
Tucson, Arizona, United States
UCLA Jules Stein Eye InstituteRecruiting
Los Angeles, California, United States
Byers Eye Institute at Stanford UniversityRecruiting
Palo Alto, California, United States
Retina Consultants of SacramentoActive Not Recruiting
Sacramento, California, United States
Massachusetts Eye and Ear InfirmaryRecruiting
Boston, Massachusetts, United States
W. K. Kellogg Eye Center, University of MichiganRecruiting
Ann Arbor, Michigan, United States
Associated Retinal Consultants, PCRecruiting
Royal Oak, Michigan, United States
Retina CenterRecruiting
Minneapolis, Minnesota, United States
Columbia University Medical CenterRecruiting
New York, New York, United States
Oregon Health & Science University Casey Eye InstituteRecruiting
Portland, Oregon, United States
Wills Eye HospitalRecruiting
Philadelphia, Pennsylvania, United States
Retina Consultants of Carolina, PARecruiting
Greenville, South Carolina, United States
St. Thomas Health / Tennessee Retina, PCRecruiting
Nashville, Tennessee, United States
Texas Retina AssociatesRecruiting
Dallas, Texas, United States
Retina Consultants of HoustonRecruiting
Houston, Texas, United States
University of WisconsinRecruiting
Madison, Wisconsin, United States
A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma · TrialPath