eligibility_summary
Eligible: clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM), no metastatic disease on imaging, and treatment-naive (prior PDT may be allowed). Exclude: known contraindications or sensitivities to the study drug or laser, or active ocular infection/disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: Phase 3, randomized, masked, sham-controlled in primary indeterminate lesions/small choroidal melanoma. Interventions: Belzupacap sarotalocan (bel‑sar, AU‑011) delivered by suprachoroidal microinjector, followed by near‑infrared laser activation, high- and low-dose arms vs sham injection/laser. Drug type and MOA: Bel‑sar is a virus‑like particle–drug conjugate (VLP) linked to a photosensitizer (IR700). It selectively binds heparan sulfate proteoglycans (HSPGs) on tumor cells. Laser activation triggers localized photochemical membrane damage, causing rapid necrotic/immunogenic cell death with potential anti‑tumor immune activation. Targets: Choroidal/uveal melanoma cells overexpressing HSPGs in the uveal tract, pathway: HSPG‑mediated tumor binding and photoactivation‑induced cell membrane disruption (immunogenic cell death). Devices: Suprachoroidal injector, infrared laser (and shams).