A Phase 2 trial of AU-011 via suprachoroidal administration with a dose escalation phase (open-label, ascending single and repeat dose) and a randomized, masked dose expansion phase designed to evaluate the safety and efficacy of AU-011 in subjects with primary indeterminate lesions and small choroidal melanoma

Primary Objective

The purpose of this research study is to test the safety and efficacy of AU-011 at different doses and different number of doses of study drug when it is injected into the suprachoroidal space with one or two laser light applications and to find out what effects, if any, it has on research participants with a choroidal melanoma tumor or indeterminate lesion.

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This study is being conducted on patients diagnosed with a type of eye cancer called choroidal melanoma or an indeterminate lesion (a growth in your eye that is suspected to be melanoma), also known as eye melanoma. People who have choroidal melanoma are usually treated with radiation therapy (either plaque brachytherapy or proton beam therapy), a surgery called enucleation (complete removal of the affected eye), or by cautious observation (watchful waiting). Aura Biosciences, Inc. is currently developing an investigational drug, AU-011, for the treatment of choroidal melanoma. Investigational means that this drug has not been approved by the United States Food and Drug Administration (FDA) but is available in research studies like this one. Research studies test how well investigational drugs work and whether they are safe to use.

Main Procedures Involved: This study will involve taking your detailed demographic, ocular, medical, and medication information, as well as blood draws, comprehensive ocular examinations and additional testing via ocular imaging. Please inquire further to get a full list of study related testing.

Duration of Participation: Your participation in this study will last a minimum of one year. After you exit from this study, you will be asked to participate in a separate long-term follow-up study (for up to an additional 4 years of follow-up).


18 to 100 years


Choroidal tumor must be no greater than 2.5 mm in height and 10 mm in width and show growth over 3 months to 2 years. Must be treatment naive with no other cancer or metastatic disease.

Type of Study


Principal Investigator
Photograph of Scott Oliver,  MD

Scott Oliver, MD

Study ID

Protocol Number: 20-1186

More information available at ClinicalTrials.gov: NCT04417530


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