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 where placement of the beam is likely to impact the study eye.
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
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov