Suprachoroidal Administration in Subjects With Metastases to the Choroid

Part of paid clinical trials in Palo Alto, California.

Sponsor
Aura Biosciences
Study ID
NCT06643884
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Eye Cancer
  • Primary Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AU-011 — DRUG
    AU-011 Via Suprachoroidal Administration with laser treatment
  • SCS Microinjector — DEVICE
    Suprachoroidal Injection Device
  • Laser — DEVICE
    Laser Administration

Study Details

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.

Key Dates

Start date
Dec 16, 2024
Status verified
Mar 2026
Primary completion
Nov 30, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 80 micrograms of bel-sar
    1 Cycle AU-011 with a dose of 80 micrograms
  • Experimental: 140 micrograms of bel-sar
    1 Cycle AU-011 with a dose of 140 micrograms
  • Experimental: 200 micrograms of bel-sar with one cycle
    1 Cycle AU-011 with a dose of 200 micrograms
  • Experimental: 200 micrograms of bel-sar with two cycles
    2 Cycles AU-011 with a dose of 200 micrograms
  • No Intervention: Observational
    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.
  • Experimental: 40 micrograms of bel-sar with one cycle
    1 Cycle AU-011 with a dose of 40 micrograms
  • Experimental: 40 micrograms of bel-sar with two cycles
    2 Cycles AU-011 with a dose of 40 micrograms

Primary Outcome Measure

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

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Byers Eye Institute at Stanford UniversityPalo AltoCalifornia94303-
Bascom Palmer Eye InstituteMiamiFlorida33136-
Massachusetts Eye and EarBostonMassachusetts02114-
Kellogg Eye CenterAnn ArborMichigan48105-
Mayo ClinicRochesterMinnesota55905-
Cleveland Clinic, Cole Eye InstituteClevelandOhio44195-
Shields and Shields, PCPhiladelphiaPennsylvania19107-
Tennessee Retina, PCNashvilleTennessee37203-
Retina Consultants of TexasBellaireTexas77401-
University of WashingtonSeattleWashington98104-

Find similar trials in Palo Alto, CA

By research site
Byers Eye Institute at Stanford University· Palo Alto, CABascom Palmer Eye Institute· Miami, FLMassachusetts Eye and Ear· Boston, MAKellogg Eye Center· Ann Arbor, MIMayo Clinic· Rochester, MNCleveland Clinic, Cole Eye Institute· Cleveland, OH

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