Study in Subjects With Small Primary Choroidal Melanoma
NCT ID: NCT03052127
Last Updated: 2024-02-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
57 participants
INTERVENTIONAL
2017-02-27
2021-01-26
Brief Summary
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Detailed Description
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Throughout the study, subjects will be monitored through medical and ophthalmic assessments. Subjects will be followed for a total of 2 years.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Single Low Dose Light-activated AU-011
Low dose Light-activated AU-011 followed by a single laser light application
Light-activated AU-011
Study treatment
Laser Activation
Study treatment
Single Medium Dose Light-activated AU-011
Medium dose Light-activated AU-011 followed by a single laser light application
Light-activated AU-011
Study treatment
Laser Activation
Study treatment
Single High Dose Light-activated AU-011
High dose Light-activated AU-011 followed by a single laser light application
Light-activated AU-011
Study treatment
Laser Activation
Study treatment
2 Repeat Medium Dose Light-activated AU-011
2 repeat medium doses of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011
Study treatment
Laser Activation
Study treatment
3 Repeat Medium Dose Light-activated AU-011
3 repeat medium doses of Light-activated AU-011 followed by a single laser light application
Light-activated AU-011
Study treatment
Laser Activation
Study treatment
Single High Dose Light-activated AU-011 x 2 lasers
High dose Light-activated AU-011 followed by two laser light applications
Light-activated AU-011
Study treatment
Laser Activation
Study treatment
3 Repeat High Dose Light-activated AU-011
3 repeat high doses of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011
Study treatment
Laser Activation
Study treatment
3 Repeat High Dose Light-activated AU-011 x 2 lasers
3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011
Study treatment
Laser Activation
Study treatment
Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers
Expansion of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications (up to 12 additional subjects)
Light-activated AU-011
Study treatment
Laser Activation
Study treatment
Observation until Documented Growth of Tumor
Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011
Study treatment
Laser Activation
Study treatment
2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers
2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011
Study treatment
Laser Activation
Study treatment
Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers
2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Light-activated AU-011
Study treatment
Laser Activation
Study treatment
Interventions
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Light-activated AU-011
Study treatment
Laser Activation
Study treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Aura Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Abhijit Narvekar, MBBS
Role: STUDY_DIRECTOR
Aura Biosciences
Locations
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Retina Associates SW, P.C.
Tucson, Arizona, United States
UCLA Jules Stein Eye Institute
Los Angeles, California, United States
Byers Eye Institute at Stanford University
Palo Alto, California, United States
Retina Consultants of Sacramento
Sacramento, California, United States
Colorado Retina Associates
Denver, Colorado, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
W. K. Kellogg Eye Center, University of Michigan
Ann Arbor, Michigan, United States
Associated Retinal Consultants, PC
Royal Oak, Michigan, United States
Retina Center
Minneapolis, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Retina Consultants of Carolina, PA
Greenville, South Carolina, United States
Retina Consultants of Houston
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AU-011-101
Identifier Type: -
Identifier Source: org_study_id
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