NCT06041256

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2023

Geographic Reach
2 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 18, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
8 months until next milestone

Results Posted

Study results publicly available

December 17, 2025

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

September 11, 2023

Results QC Date

October 24, 2025

Last Update Submit

December 16, 2025

Conditions

Corneal EdemaCorneal Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data

    Best-corrected visual acuity was assessed using Early Treatment Diabetic Retinopathy Study(ETDRS) method, standard for vision testing. Standardized Sloan letter charts with 5 letters per line, decreasing by 0.1 logarithm of minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. Data presented represent number of participants with available BCVA measurements at Month 6, with those who had missing data, underwent rescue surgery before Month 6, or discontinued study prior to Month 6 imputed as non-responders.

    Month 6

Secondary Outcomes (6)

  • Change From Baseline in BCVA at Month 6

    Baseline (Day 1) and at Month 6

  • Change From Baseline in Central Corneal Thickness (CCT) at Month 6

    Baseline (Day 1) and at Month 6

  • Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data

    At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12

  • Change From Baseline in BCVA at All Other Timepoints

    Baseline (Day 1) and at Week 4, Months 2, 3, 4.5, 6, 9 and 12

  • Change From Baseline in CCT at All Other Timepoints

    Baseline (Day 1) and at Weeks 1 and 4, Months 2, 3, 4.5, 6, 9, and 12

  • +1 more secondary outcomes

Study Arms (5)

AURN001 High

EXPERIMENTAL

Neltependocel High and Rho-associated protein kinase

Combination Product: AURN001

AURN001 Medium

EXPERIMENTAL

Neltependocel Medium and Rho-associated protein kinase

Combination Product: AURN001

AURN001 Low

EXPERIMENTAL

Neltependocel Low and Rho-associated protein kinase

Combination Product: AURN001

Neltependocel

EXPERIMENTAL

Neltependocel - High

Biological: Corneal Endothelial Cells

ROCK

EXPERIMENTAL

Rho-associated protein kinase (ROCK)

Drug: Y27632

Interventions

AURN001COMBINATION_PRODUCT

Corneal Endothelial Cells and Y27632

AURN001 HighAURN001 LowAURN001 Medium
Y27632DRUG

Y27632

ROCK
Corneal Endothelial CellsBIOLOGICAL

Corneal Endothelial Cells

Neltependocel

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Aurion Biotech site

Little Rock, Arkansas, 72205, United States

Location

Aurion Biotech site

Los Angeles, California, 90067, United States

Location

Aurion Biotech site

San Francisco, California, 94158, United States

Location

Aurion Biotech site

Atlanta, Georgia, 30339, United States

Location

Aurion Biotech site

Indianapolis, Indiana, 46260, United States

Location

Aurion Biotech site

Wichita, Kansas, 67206, United States

Location

Aurion Biotech site

Minnetonka, Minnesota, 55305, United States

Location

Aurion Biotech site

Garden City, New York, 11576, United States

Location

Aurion Biotech site

Winston-Salem, North Carolina, 27157, United States

Location

Aurion Biotech site

Cincinnati, Ohio, 45242, United States

Location

Aurion Biotech site

Oklahoma City, Oklahoma, 73104, United States

Location

Aurion Biotech site

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Aurion Biotech site

Sioux Falls, South Dakota, 57108, United States

Location

Aurion Biotech site

Houston, Texas, 77027, United States

Location

Aurion Biotech site

Houston, Texas, 77055, United States

Location

Aurion Biotech site

Norfolk, Virginia, 23502, United States

Location

Aurion Biotech site

Seattle, Washington, 98125, United States

Location

Aurion Biotech site

Vancouver, British Columbia, V5Z 1K1 CAN, Canada

Location

Aurion Biotech site

Oakville, Ontario, L6H 0J8 CAN, Canada

Location

Aurion Biotech site

Toronto, Ontario, M5T 3A9 CAN, Canada

Location

MeSH Terms

Conditions

Corneal Edema

Interventions

Y 27632

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Results Point of Contact

Title
Study director
Organization
Aurion Biotech, Inc.
clinicalaffairs@aurionbiotech.com
+1-857-639-4143

Study Officials

  • Study Manager, OD

    Aurion Biotech

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 18, 2023

Study Start

October 18, 2023

Primary Completion

October 25, 2024

Study Completion

April 15, 2025

Last Updated

December 17, 2025

Results First Posted

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(17)CA(3)