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A Phase 1/2 Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)

NCT06041256 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2025-12-17

Study results available
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Summary

The goal of this clinical trial is to compare different doses of AURN001 in patients with corneal edema secondary to corneal endothelial dysfunction. The main questions the clinical trial aims to answer are whether AURN001 effective and safe. Participants will receive a single injection of AURN001. A comparison between low, medium, and high doses of AURN001 against the contribution of each element, cells alone and Y27632 alone, will be conducted to determine the effects on corneal edema.

Conditions

  • Corneal Edema
  • Corneal Endothelial Dysfunction

Interventions

COMBINATION_PRODUCT

AURN001

Corneal Endothelial Cells and Y27632

BIOLOGICAL

Corneal Endothelial Cells

Corneal Endothelial Cells

DRUG

Y27632

Y27632

Sponsors & Collaborators

  • Aurion Biotech

    lead INDUSTRY

Principal Investigators

  • Study Manager, OD · Aurion Biotech

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2024-10-25
Completion
2025-04-15
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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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 NCT06041256 on ClinicalTrials.gov