Clinical trial NCT03941379: A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma
Official title: A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Choroidal Melanoma
Indeterminate Lesions of Eye
Keywords: Choroidal Melanoma
Indeterminate Lesions of Eye
Lead sponsor: Aura Biosciences
Sponsor class: INDUSTRY
First posted: 2019-05-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with primary Indeterminate Lesions or Choroidal Melanoma who participated in previous Aura Biosciences sponsored clinical trial.

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.

Detailed 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.

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

Primary outcomes:
measure: Incidence of Adverse Events and Serious Adverse Events that are related to IL/CM treatment with bel-sar, sham, SoC or alternative treatment.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Retina Associates SW, P.C.
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Jules Stein Eye Institute
state: California
city: Palo Alto
country: United States
facility: Byers Eye Institute at Stanford University
state: California
city: Sacramento
country: United States
facility: Retina Consultants of Sacramento
state: California
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
city: Ann Arbor
country: United States
facility: W. K. Kellogg Eye Center, University of Michigan
state: Michigan
city: Royal Oak
country: United States
facility: Associated Retinal Consultants, PC
state: Michigan
city: Minneapolis
country: United States
facility: Retina Center
state: Minnesota
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University Casey Eye Institute
state: Oregon
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
city: Greenville
country: United States
facility: Retina Consultants of Carolina, PA
state: South Carolina
city: Nashville
country: United States
facility: St. Thomas Health / Tennessee Retina, PC
state: Tennessee
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Aura Biosciences Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References: