Study of Safety and Tolerability of EO2002 in the Treatment of Corneal Edema
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bullous Keratopathy
- Corneal Edema
- Corneal Endothelial Dysfunction
- Corneal Endothelial Dystrophy
- Endothelial Dysfunction
- Fuchs Dystrophy
- Fuchs Endothelial Corneal Dystrophy
- Moderate Corneal Endothelial Decompensation
- Pseudophakic Bullous Keratopathy
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Open-Label, Dose-Escalation StudyMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 125 years
- Gender
- Both males and females
Description
This phase 1, prospective, multi-center, open-label, dose-escalation study is designed to evaluate the safety and tolerability of EO2002 with and without endothelial brushing (EB) or Descemet Stripping (DS) in eyes with corneal edema secondary to corneal endothelial dysfunction that qualify for surg...
This phase 1, prospective, multi-center, open-label, dose-escalation study is designed to evaluate the safety and tolerability of EO2002 with and without endothelial brushing (EB) or Descemet Stripping (DS) in eyes with corneal edema secondary to corneal endothelial dysfunction that qualify for surgery involving full-thickness corneal transplantation or EK. Three doses will be studied in approximately 18 study participants that meet the inclusion/exclusion criteria. Safety and tolerability will be the primary focus for 26 weeks following treatment with EO2002.
Tracking Information
- NCT #
- NCT04894110
- Collaborators
- Not Provided
- Investigators
- Study Director: Noelia Kunzevitzky Emmecell
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