A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 2 Study of EO2002 in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction (EMERALD)
This study will evaluate the safety and effectiveness of a single injection of EO2002 at one of two dose levels (150,000 or 500,000 magnetic human corneal endothelial cells \[mHCECs\]), compared with a placebo injection, in participants with corneal edema caused by corneal endothelial dysfunction.
• Symptomatic central corneal edema that is primarily responsible for loss of vision associated with endothelial dysfunction which may be secondary to Fuchs corneal dystrophy or pseudophakic bullous keratopathy.
• Early Treatment Diabetic Retinopathy Study (ETDRS)-best-corrected distance visual acuity between 20 and 65 letters inclusive (≥ 20 and ≤ 65 letters)
• Central corneal thickness ≥ 600 μm and ≤ 1,000 μm, OR Medical Monitor review and approval based on either:
‣ Historical CCT increased by ≥ 50 μm OR
⁃ Findings of edema by corneal tomography or Anterior Segment Optical Coherence Tomography (AS-OCT).
• Participant is considered a surgical candidate for full-thickness corneal transplantation or endothelial (partial thickness) keratoplasty (EK) consistent with standard-of-care indications.