Suprachoroidal Administration in Subjects With Metastases to the Choroid
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAura Biosciences
About this trial
The primary objective is to assess the safety and tolerability of bel-sar treatment in subjects with metastases to the choroid from any primary solid tumor.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have a clinical diagnosis of Metastases to the Choroid, from a histopathologically or cytologically confirmed tumor.
Have at least one Metastases to the Choroid in the study eye
Disqualifiers
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.
Must not be planning or expecting to switch/add systemic antineoplastic therapies during treatment
Trial design
Design model
Sequential
Treatments tested in this trial
AU-011
DrugAU-011 Via Suprachoroidal Administration with laser treatment
SCS Microinjector
DeviceSuprachoroidal Injection Device
Laser
DeviceLaser Administration
Treatment groups
24 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: 80 micrograms of bel-sarExperimental treatment 3 interventions
Group B: 140 micrograms of bel-sarExperimental treatment 3 interventions
Group C: 200 micrograms of bel-sar with one cycleExperimental treatment 3 interventions
Group D: 200 micrograms of bel-sar with two cyclesExperimental treatment 3 interventions
Group E: ObservationalNo intervention 0 interventions
Group F: 40 micrograms of bel-sar with one cycleExperimental treatment 3 interventions
Group G: 40 micrograms of bel-sar with two cyclesExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Change from baseline in choroidal tumor thickness on B-scan ultrasonography (B-scan) 4 weeks after completion of treatment.
B-Scan Ultrasonography
Time frame
4 weeks after completion of treatment2
Change from baseline in choroidal tumor largest basal diameter (LBD) on fundus photos 4 weeks after completion of treatment.
Fundus photos
Time frame
4 weeks after completion of treatmentSponsors and contacts
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Source ClinicalTrials.gov