PVEK Corneal Implant For Treatment of Corneal Edema

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)

NCT Number	NCT07325097
Lead Sponsor	Precise Bio
Conditions	Corneal Edema, Fuchs' Endothelial Dystrophy, Pseudophakic Bullous Keratopathy, Corneal Endothelial Dysfunction
Enrollment	15 participants
Start Date	2025-09-16
Primary Completion	2027-03 (estimated)
Study Completion	2027-09 (estimated)
Updated on ClinicalTrials.gov	2026-01-12