NCT07368959

Brief Summary

The purpose of this study is to assess the efficacy and safety of single injection dose of AURN001 compared with placebo in adult participants with corneal edema secondary to corneal endothelial dysfunction.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
20mo left

Started Feb 2026

Geographic Reach
1 country

12 active sites

Status
recruiting

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

Study Progress11%
Feb 2026Jan 2028

First Submitted

Initial submission to the registry

January 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

February 19, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

January 23, 2026

Last Update Submit

April 7, 2026

Conditions

Corneal EdemaCorneal Endothelial DysfunctionFuchs Endothelial Corneal DysfunctionPseudophakic Bullous Keratopathy (PBK)

Keywords

Best Corrected Visual AcuityCentral corneal thicknessHuman Corneal Endothelial CellsNeltependocelPostsurgical endothelial dysfunctionKeratoplastyPseudophakic Corneal Edema (PCE)Corneal Endothelial CellsEndothelial CellsAURN001Y-27632Endothelial KeratoplastyCorneal Endothelial Cell Therapy

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants who achieve a ≥ 15-letter improvement (3-line gain) from baseline in Best Corrected Visual Acuity (BCVA) at Month 6

    At Month 6

Secondary Outcomes (2)

  • Change from baseline in non-contact Central Corneal Thickness (CCT) at Month 6

    Baseline (Day 1) and At Month 6

  • Change from baseline in BCVA at Month 6

    Baseline (Day 1) and At Month 6

Study Arms (2)

AURN001

EXPERIMENTAL

Participants will receive single dose of AURN001

Drug: Combination Product: AURN001 + Y-27632

Placebo

PLACEBO COMPARATOR

Participants will receive single dose of placebo control.

Other: Placebo

Interventions

Combination Product: AURN001 + Y-27632DRUG

AURN001 will be injected to the anterior chamber of the eye.

AURN001
PlaceboOTHER

Placebo control will be injected to the anterior chamber of the eye.

Placebo

Eligibility Criteria

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

You may qualify if:

  • (All ocular criteria apply to the study eye unless noted otherwise)
  • Have corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)
  • BCVA between 65 ETDRS letters (approximate 20/50 Snellen equivalent) and 5 ETDRS letters (approximate 20/800 Snellen equivalent)
  • Be pseudophakic with PCIOL

You may not qualify if:

  • (All ocular criteria apply to the study eye unless noted otherwise)
  • Have progressive corneal dystrophies or degenerations
  • Have visually significant corneal or other ocular pathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Investigational Site 2

Mesa, Arizona, 85206, United States

RECRUITING

Investigational Site 6

Little Rock, Arkansas, 72205, United States

RECRUITING

Investigational Site 9

Fort Collins, Colorado, 80528, United States

RECRUITING

Investigational Site 7

Atlanta, Georgia, 30339, United States

RECRUITING

Investigational Site 4

Kansas City, Missouri, 64154, United States

RECRUITING

Investigational Site 11

Leland, North Carolina, 28451, United States

RECRUITING

Investigational Site 5

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Investigational Site 3

Cynwyd, Pennsylvania, 19004, United States

RECRUITING

Investigational Site 10

Plymouth Meeting, Pennsylvania, 19462, United States

RECRUITING

Investigational Site 12

Ladson, South Carolina, 29456, United States

RECRUITING

Investigational Site 8

San Antonio, Texas, 78209, United States

RECRUITING

Investigational Site 1

Spring, Texas, 77388, United States

RECRUITING

MeSH Terms

Conditions

Corneal Edema

Interventions

Y 27632

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Central Study Contacts

Aurion Study Team

CONTACT

1-857-639-4168ASTRA@aurionbiotech.com

Study Design

Study Type
interventional
Phase
phase 3
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

January 23, 2026

First Posted

January 27, 2026

Study Start

February 19, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(12)