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Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

NCT04417530 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-03-03

No results posted yet for this study

Summary

The primary objective is to determine the safety, tolerability, and preliminary efficacy of belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).

Conditions

Interventions

DRUG

AU-011

AU-011 Via Suprachoroidal Administration

DEVICE

Suprachoroidal Microinjector

Suprachoroidal Injection Device

DEVICE

PDT Laser

Laser Administration

Sponsors & Collaborators

  • Aura Biosciences

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Aura Biosciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-05
Primary Completion
2024-04-22
Completion
2024-04-22
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04417530 on ClinicalTrials.gov