AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction

Purpose

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.

Conditions

  • Corneal Edema
  • Corneal Endothelial Dysfunction
  • Fuchs Endothelial Corneal Dysfunction
  • Pseudophakic Bullous Keratopathy (PBK)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

(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 Key Ocular

Exclusion Criteria

(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 Other inclusion/exclusion criteria may apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
AURN001 		Participants will receive single dose of AURN001
  • Drug: Combination Product: AURN001 + Y-27632
    AURN001 will be injected to the anterior chamber of the eye.
Placebo Comparator
Placebo 		Participants will receive single dose of placebo control.
  • Other: Placebo
    Placebo control will be injected to the anterior chamber of the eye.

Recruiting Locations

Investigational Site 2
Mesa, Arizona 85206

Investigational Site 6
Little Rock, Arkansas 72205

Investigational Site 9
Fort Collins, Colorado 80528

Investigational Site 7
Atlanta, Georgia 30339

Investigational Site 4
Kansas City, Missouri 64154

Investigational Site 11
Leland, North Carolina 28451

Investigational Site 3
Cynwyd, Pennsylvania 19004

Investigational Site 10
Plymouth Meeting, Pennsylvania 19462

Investigational Site 12
Ladson, South Carolina 29456

Investigational Site 8
San Antonio, Texas 78209

Investigational Site 1
Spring, Texas 77388

More Details

Status
Recruiting
Sponsor
Aurion Biotech

Study Contact

Aurion Study Team
1-857-639-4168
ASTRA@aurionbiotech.com