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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have no evidence of metastatic disease confirmed by imaging
Be treatment naïve for IL/CM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
Study Summary
This trial is testing a new treatment for small choroidal melanoma. The treatment is an injection into the suprachoroidal space and the primary objective is to assess the safety and efficacy of this new treatment.
Who is the study for?
This trial is for individuals with a clinical diagnosis of primary indeterminate lesions or small choroidal melanoma, who haven't had any previous treatments for these conditions and have no signs of the cancer spreading to other parts of the body. People can't join if they are allergic or sensitive to the study drug or laser treatment, or if they have an active eye disease.Check my eligibility
What is being tested?
The trial is testing belzupacap sarotalocan (AU-011) delivered into the eye using a special microinjector followed by PDT laser treatment. The goal is to see how safe and effective this approach is in treating small tumors in the eye related to melanoma.See study design
What are the potential side effects?
Potential side effects may include discomfort at injection site, inflammation inside the eye, changes in vision, and sensitivity to light due to AU-011 and PDT laser therapy. Specific side effect profiles will be monitored closely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My scans show no signs of cancer spread.
Select...
I have not received any treatments for my condition.
Select...
I have been diagnosed with a small eye melanoma or an uncertain eye lesion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment related AEs and treatment related serious adverse events (SAEs).
Secondary outcome measures
Time to reach tumor progression
Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.
Trial Design
6Treatment groups
Experimental Treatment
Group I: Cohort 6 AU-011 & LaserExperimental Treatment3 Interventions
High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment.
Group II: Cohort 5 AU-011 & LaserExperimental Treatment3 Interventions
AU-011/laser applications from Cohorts 1 to 3 administered weekly for 3 treatments. Up to 2 cycles of this regimen may be administered and subjects have the option of receiving a third cycle of treatment.
Group III: Cohort 4 AU-011 & LaserExperimental Treatment3 Interventions
Highest tolerated dose of AU-011/laser applications from Cohorts 1 to 3 administered weekly for 2 treatments
Group IV: Cohort 3 AU-011 & LaserExperimental Treatment3 Interventions
Medium dose of AU-011 + 2 laser applications
Group V: Cohort 2 AU-011 & LaserExperimental Treatment3 Interventions
Medium dose of AU-011 + 1 laser application
Group VI: Cohort 1 AU-011 & LaserExperimental Treatment3 Interventions
Low dose of AU-011 + 1 laser application
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Who is running the clinical trial?
Aura BiosciencesLead Sponsor
5 Previous Clinical Trials
680 Total Patients Enrolled
4 Trials studying Choroidal Melanoma
659 Patients Enrolled for Choroidal Melanoma
Medical MonitorStudy DirectorAura Biosciences
1,669 Previous Clinical Trials
987,410 Total Patients Enrolled
3 Trials studying Choroidal Melanoma
602 Patients Enrolled for Choroidal Melanoma
Abhijit Narvekar, MBBSStudy DirectorAura Biosciences
1 Previous Clinical Trials
57 Total Patients Enrolled
1 Trials studying Choroidal Melanoma
57 Patients Enrolled for Choroidal Melanoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My scans show no signs of cancer spread.I have an active eye condition.I have not received any treatments for my condition.I have been diagnosed with a small eye melanoma or an uncertain eye lesion.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 3 AU-011 & Laser
- Group 2: Cohort 4 AU-011 & Laser
- Group 3: Cohort 5 AU-011 & Laser
- Group 4: Cohort 1 AU-011 & Laser
- Group 5: Cohort 2 AU-011 & Laser
- Group 6: Cohort 6 AU-011 & Laser
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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