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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03052127
Other study ID # AU-011-101
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date February 27, 2017
Est. completion date January 26, 2021

Study information

Verified date January 2024
Source Aura Biosciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective is to assess the safety, immunogenicity and efficacy of one of three dose levels and repeat dose regimens of Light-activated AU-011 and one or two laser applications for the treatment of subjects with primary choroidal melanoma.


Description:

This is a phase 1B/2 open-label, ascending single and repeat dose clinical trial designed to evaluate the safety and efficacy of Light-activated AU-011 for the treatment of subjects with small primary choroidal melanoma. Throughout the study, subjects will be monitored through medical and ophthalmic assessments. Subjects will be followed for a total of 2 years.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date January 26, 2021
Est. primary completion date January 26, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of choroidal melanoma Exclusion Criteria: - Have known contraindications or sensitivities to the study drug

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Light-activated AU-011
Study treatment
Device:
Laser Activation
Study treatment

Locations

Country Name City State
United States W. K. Kellogg Eye Center, University of Michigan Ann Arbor Michigan
United States Massachusetts Eye and Ear Infirmary Boston Massachusetts
United States Colorado Retina Associates Denver Colorado
United States Retina Consultants of Carolina, PA Greenville South Carolina
United States Retina Consultants of Houston Houston Texas
United States UCLA Jules Stein Eye Institute Los Angeles California
United States Retina Center Minneapolis Minnesota
United States Columbia University Medical Center New York New York
United States Byers Eye Institute at Stanford University Palo Alto California
United States Wills Eye Hospital Philadelphia Pennsylvania
United States Associated Retinal Consultants, PC Royal Oak Michigan
United States Retina Consultants of Sacramento Sacramento California
United States Retina Associates SW, P.C. Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Aura Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 Adverse events will be summarized by presenting the number and percentage of participants having any adverse event. Informed consent through 1-2 years
Secondary Immunogenicity (Anti-AU-011 Antibody Analysis) Percentage of Participants with Anti-AU-011 Antibodies (Anti-Drug Antibody, ADA) Screening to various time points through 24 months
Secondary Tumor Size (Thickness) Measured by Ultrasonography [Efficacy] Change from Baseline in maximum tumor thickness (in millimeters) assessed at each study visit using B-scan ultrasound. Change from baseline following treatment and at each subsequent visit through Week 52
Secondary Tumor Size (Diameter) Measured by Fundus Photography [Efficacy] Change from Baseline in tumor Largest Basal Diameter (LBD) assessed at each study visit based on fundus photos (millimeters) in participants treated with AU-011. Change from baseline following treatment and at each subsequent visit through Week 52
Secondary Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye Change from Baseline in Best Corrected Visual Acuity using ETDRS letters in Study Eye at each study visit. Change from baseline following treatment and at each subsequent visit through Week 52
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