NCT03052127

Study in Subjects With Small Primary Choroidal Melanoma

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Aura Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Uveal Melanoma
• Ocular Melanoma
• Choroidal Melanoma

Interventions

Type	Name	Description
DRUG	Light-activated AU-011	Study treatment
DEVICE	Laser Activation	Study treatment

Timeline

• Start date: 2017-02-27
• Primary completion: 2021-01-26
• Completion: 2021-01-26
• First posted: 2017-02-14
• Last updated: 2024-02-01
• Results posted: 2024-02-01

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study