A Prospective, Single Arm Study to Assess the Safety and Tolerability of PVEK Corneal Implant for the Treatment of Corneal Edema (CIFRE)

NCT07325097 Phase 1 RECRUITING

The goal of this clinical trial is to learn if PVEK, a corneal implant , is safe and well tolerated for people with corneal swelling caused by Fuchs' endothelial dystrophy or pseudophakic bullous keratopathy who need endothelial keratoplasty. The main questions it aims to answer are: What side effects may happen after the PVEK implant? How many participants can complete the first 6 months after surgery without needing another treatment because the implant did not help enough or was not tolerable? This is a Phase 1 (first-in-human) study with one study group, meaning all participants receive the PVEK implant (there is no placebo or comparison group). About 15 participants will take part and will be followed for up to 12 months after surgery. Participants will: Complete screening tests (including eye exams and routine health checks) Have the PVEK implantation surgery Use prescribed eye drops after surgery Return for follow-up visits over the next 12 months for eye exams and tests (such as vision testing, eye pressure checks, and eye scans)

Details

Lead sponsor	Precise Bio
Phase	Phase 1
Status	RECRUITING
Enrolment	15
Start date	2025-09-16
Completion	2027-09

Conditions

• Corneal Edema
• Fuchs' Endothelial Dystrophy
• Pseudophakic Bullous Keratopathy
• Corneal Endothelial Dysfunction

Interventions

• Precise Vision Endothelial Keratoplasty (PVEK) Implant

Primary outcomes

• Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs) — 6 months
  Number and percentage of participants with any adverse event (AE) and any treatment-emergent adverse event (TEAE) occurring after PVEK implantation.
• Proportion of participants completing 6-month follow-up without seeking alternative treatment — 6 months
  Percentage of participants who complete the 6-month follow-up without seeking alternative treatment due to perceived lack of efficacy or intolerability of side effects.

Countries

Armenia, Israel