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OpenTrials
Completed

NCT Number: NCT03052127

Study in Subjects With Small Primary Choroidal Melanoma

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.

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Key information

Conditions

Uveal Melanoma Choroidal Melanoma Eye Diseases Eye Neoplasms Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ocular Melanoma Uveal Diseases Uveal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Retina Associates SW, P.C., Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of choroidal melanoma

Exclusion criteria

  • Have known contraindications or sensitivities to the study drug

Treatment and study plan

Light-activated AU-011

Drug

Study treatment

LASER activation

Device

Study treatment

Other names: PDT Laser

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011

    Time frame: Informed consent through 1-2 years

    Adverse events will be summarized by presenting the number and percentage of participants having any adverse event.

Secondary outcomes

  1. Immunogenicity (Anti-AU-011 Antibody Analysis)

    Time frame: Screening to various time points through 24 months

    Percentage of Participants with Anti-AU-011 Antibodies (Anti-Drug Antibody, ADA)

  2. Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]

    Time frame: Change from baseline following treatment and at each subsequent visit through Week 52

    Change from Baseline in maximum tumor thickness (in millimeters) assessed at each study visit using B-scan ultrasound.

  3. Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]

    Time frame: Change from baseline following treatment and at each subsequent visit through Week 52

    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.

  4. Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye

    Time frame: Change from baseline following treatment and at each subsequent visit through Week 52

    Change from Baseline in Best Corrected Visual Acuity using ETDRS letters in Study Eye at each study visit.

Sponsors and collaborators

Lead sponsor

Aura Biosciences

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 14, 2017
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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