AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Recruiting
Phase 3
Interventional Study
Corneal Edema
Corneal Endothelial Dysfunction
Fuchs Endothelial Corneal Dysfunction
Pseudophakic Bullous Keratopathy (PBK)
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- Aurion Biotech · Industry
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About This Trial
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 Locations
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Eligibility 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 e…
Contacts