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Virus Therapy

Bel-sar for Eye Cancer

Phase 2

Waitlist Available

Research Sponsored by Aura Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a clinical diagnosis of Choroidal Metastasis, from a histopathologically or cytologically confirmed breast or lung primary tumor

Have a single Choroidal Metastasis in only 1 eye, and no Choroidal Metastasis in the other eye (i.e., unilateral, unifocal Choroidal Metastasis)

Must not have

Active ocular infection or disease

Must not have evidence of a primary tumor or metastatic lesion in the brain requiring treatment with radiation therapy per the primary treating oncologist's assessment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks after completion of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to evaluate how safe and well-tolerated bel-sar treatment is for individuals with eye tumors that have spread from breast or lung cancer.

Who is the study for?

This trial is for individuals with choroidal metastasis, which are cancerous growths in the eye that have spread from either breast or lung tumors. Participants must meet certain health standards to be eligible.

What is being tested?

The study is testing the safety and tolerability of a treatment called bel-sar, administered through a special injection into the eye (suprachoroidal space), sometimes followed by laser treatment.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, inflammation inside the eye, changes in vision, and other reactions related to the drug or procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a diagnosis of eye cancer that originated from breast or lung cancer.

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I have cancer spread to only one eye and not the other.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active eye infection or disease.

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I don't have brain tumors needing radiation according to my cancer doctor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks after completion of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks after completion of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after completion of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in choroidal tumor largest basal diameter (LBD) on fundus photos 4 weeks after completion of treatment.

Change from baseline in choroidal tumor thickness on B-scan ultrasonography (B-scan) 4 weeks after completion of treatment.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: 80 micrograms of bel-sarExperimental Treatment3 Interventions

1 Cycle AU-011 with a dose of 80 micrograms

Group II: 200 micrograms of bel-sar with two cyclesExperimental Treatment3 Interventions

2 Cycles AU-011 with a dose of 200 micrograms

Group III: 200 micrograms of bel-sar with one cycleExperimental Treatment3 Interventions

1 Cycle AU-011 with a dose of 200 micrograms

Group IV: 160 micrograms of bel-sarExperimental Treatment3 Interventions

1 Cycle AU-011 with a dose of 160 micrograms

Group V: ObservationalActive Control1 Intervention

Subjects that meet trial inclusion, but do not meet criteria for enrollment into the bel-sar treatment cohorts, may be enrolled in this cohort. The observational cohort will not receive bel-sar treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AU-011

2020

Completed Phase 2

~30

Laser

2008

Completed Phase 4

~2170