Melanoma Clinical Trial

A Registry of Patients With Primary Indeterminate Lesions or Choroidal Melanoma

Summary

The purpose of this observational research study is to follow participants who have been treated with either AU-011 or observation and/or received standard of care therapy while participating in a previous Aura Biosciences clinical research study to assess the long-term safety and effectiveness of AU-011 and standard of care therapy. 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.

View Full Description

Full Description

This is a multi-center long-term observational Registry of patients with Primary Indeterminate Lesions or Choroidal Melanoma.

The Registry will initially be open to patients who have previously participated in an Aura Biosciences sponsored clinical trial for their primary Choroidal Melanoma or Indeterminate Lesions.

All patients 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 patients with CM or IL; these patients are routinely followed at 6-month intervals by their treating physician.

View Eligibility Criteria

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 or assigned to an observation cohort in a previous Aura sponsored clinical trial.

Exclusion Criteria:

None

Study is for people with:

Melanoma

Estimated Enrollment:

500

Study ID:

NCT03941379

Recruitment Status:

Recruiting

Sponsor:

Aura Biosciences

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There are 15 Locations for this study

See Locations Near You

Retina Associates SW, P.C.
Tucson Arizona, 85710, United States More Info
Amy Merz
Contact
UCLA Jules Stein Eye Institute
Los Angeles California, 90095, United States More Info
Rosaleen Ostrick
Contact
Byers Eye Institute at Stanford University
Palo Alto California, 94303, United States More Info
Mariana Nunez
Contact
Retina Consultants of Sacramento
Sacramento California, 95825, United States More Info
Erin Nickerman
Contact
Massachusetts Eye and Ear Infirmary
Boston Massachusetts, 02114, United States More Info
Grayson Hanlon
Contact
W. K. Kellogg Eye Center, University of Michigan
Ann Arbor Michigan, 48105, United States More Info
Pamela Campbell
Contact
Associated Retinal Consultants, PC
Royal Oak Michigan, 48073, United States More Info
Kendra Mellert
Contact
Retina Center
Minneapolis Minnesota, 55404, United States More Info
Andi Gilchrist, BS CMSS
Contact
Columbia University Medical Center
New York New York, 10032, United States More Info
Ellen Alt
Contact
Oregon Health & Science University Casey Eye Institute
Portland Oregon, 97239, United States More Info
Ann Lundquist
Contact
Wills Eye Hospital
Philadelphia Pennsylvania, 19107, United States More Info
Brian Sorum
Contact
Retina Consultants of Carolina, PA
Greenville South Carolina, 29605, United States More Info
Lauren Frazier
Contact
St. Thomas Health / Tennessee Retina, PC
Nashville Tennessee, 37203, United States More Info
Lisa Walden
Contact
Texas Retina Associates
Dallas Texas, 75231, United States More Info
Sally Arceneaux
Contact
Retina Consultants of Houston
Houston Texas, 77030, United States More Info
Allison Stroh
Contact

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Estimated Enrollment:

500

Study ID:

NCT03941379

Recruitment Status:

Recruiting

Sponsor:


Aura Biosciences

How clear is this clinincal trial information?

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