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

NCT ID: NCT06041256

Last Updated: 2025-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-18

Study Completion Date

2025-04-15

Brief Summary

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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.

Detailed Description

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Conditions

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Corneal Edema Corneal Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AURN001 High

Neltependocel High and Rho-associated protein kinase

Group Type EXPERIMENTAL

AURN001

Intervention Type COMBINATION_PRODUCT

Corneal Endothelial Cells and Y27632

AURN001 Medium

Neltependocel Medium and Rho-associated protein kinase

Group Type EXPERIMENTAL

AURN001

Intervention Type COMBINATION_PRODUCT

Corneal Endothelial Cells and Y27632

AURN001 Low

Neltependocel Low and Rho-associated protein kinase

Group Type EXPERIMENTAL

AURN001

Intervention Type COMBINATION_PRODUCT

Corneal Endothelial Cells and Y27632

Neltependocel

Neltependocel - High

Group Type EXPERIMENTAL

Corneal Endothelial Cells

Intervention Type BIOLOGICAL

Corneal Endothelial Cells

ROCK

Rho-associated protein kinase (ROCK)

Group Type EXPERIMENTAL

Y27632

Intervention Type DRUG

Y27632

Interventions

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AURN001

Corneal Endothelial Cells and Y27632

Intervention Type COMBINATION_PRODUCT

Corneal Endothelial Cells

Corneal Endothelial Cells

Intervention Type BIOLOGICAL

Y27632

Y27632

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have a diagnosis of corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)
* BCVA between 65 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (i.e., 0.4 LogMAR or approximate 20/50 Snellen equivalent) and 5 ETDRS letters (i.e., 1.6 LogMAR or approximate 20/800 Snellen equivalent)

Exclusion Criteria

* Have pre-operative corneal epithelial, sub-epithelial or stromal scarring or other opacity that is paracentral/central and visually significant, but not suspected to be secondary to corneal endothelial disease with the potential to improve from treatment in the study eye
* Have history or presence of an ocular disease other than corneal endothelial dysfunction that could affect vision or safety assessments
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aurion Biotech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Manager, OD

Role: STUDY_DIRECTOR

Aurion Biotech

Locations

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Aurion Biotech site

Little Rock, Arkansas, United States

Site Status

Aurion Biotech site

Los Angeles, California, United States

Site Status

Aurion Biotech site

San Francisco, California, United States

Site Status

Aurion Biotech site

Atlanta, Georgia, United States

Site Status

Aurion Biotech site

Indianapolis, Indiana, United States

Site Status

Aurion Biotech site

Wichita, Kansas, United States

Site Status

Aurion Biotech site

Minnetonka, Minnesota, United States

Site Status

Aurion Biotech site

Garden City, New York, United States

Site Status

Aurion Biotech site

Winston-Salem, North Carolina, United States

Site Status

Aurion Biotech site

Cincinnati, Ohio, United States

Site Status

Aurion Biotech site

Oklahoma City, Oklahoma, United States

Site Status

Aurion Biotech site

Bala-Cynwyd, Pennsylvania, United States

Site Status

Aurion Biotech site

Sioux Falls, South Dakota, United States

Site Status

Aurion Biotech site

Houston, Texas, United States

Site Status

Aurion Biotech site

Houston, Texas, United States

Site Status

Aurion Biotech site

Norfolk, Virginia, United States

Site Status

Aurion Biotech site

Seattle, Washington, United States

Site Status

Aurion Biotech site

Vancouver, British Columbia, Canada

Site Status

Aurion Biotech site

Oakville, Ontario, Canada

Site Status

Aurion Biotech site

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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ABA-1

Identifier Type: -

Identifier Source: org_study_id