Condition: Corneal Edema · Fuchs' Endothelial Dystrophy · Pseudophakic Bullous Keratopathy · Sponsor: Precise Bio
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)
This description comes directly from the study's public registry record.
Amos Eitan · +972 54 7854387 · amos.eitan@precise-bio.com
Lior Rosenberg Belmaker · +972 52 385 8875 · lior.rb@precise-bio.com
Always discuss trial participation with your own doctor first.
| Ophthalmological Center After S.V.Malayan | Yerevan, Armenia | Not Yet Recruiting |
| Sharei Zedek Medical Center | Jerusalem, Jerusalem, Israel | Not Yet Recruiting |
| Rambam Medical Center | Haifa, Israel | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07325097