Study of Cryopreserved AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dy… (NCT06630169) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Cryopreserved AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
El Salvador25 participantsStarted 2024-09-16
Plain-language summary
The purpose of this study is to assess the safety and efficacy of cryopreserved AURN001 in patients with corneal edema secondary to endothelial dysfunction.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion Criteria:
* Have a diagnosis of corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)
* BCVA no worse than 5 ETDRS letters (i.e., 1.6 LogMAR or approximate 20/800 Snellen equivalent).
Exclusion Criteria:
* 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