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

Aurion Biotech

Status and phase: Begins enrollment in 2 months; Phase 3

Conditions: Corneal Edema; Fuchs Endothelial Corneal Dysfunction; Corneal Endothelial Dysfunction; Pseudophakic Bullous Keratopathy (PBK)

Treatments: Other: Placebo; Drug: Combination Product: AURN001 + Y-27632

Study type: Interventional

Funder types: Industry

Identifiers

NCT07368959

ABA-3

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Ocular 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

120 participants in 2 patient groups, including a placebo group

AURN001

Experimental group

Description:

Participants will receive single dose of AURN001

Treatment:

Drug: Combination Product: AURN001 + Y-27632

Placebo

Placebo Comparator group

Description:

Participants will receive single dose of placebo control.

Treatment:

Other: Placebo