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)
None
None
Single group
Precise Vision Endothelial Keratoplasty (PVEK) Implant
Combination productPVEK is a tissue-engineered corneal endothelial implant intended to treat corneal endothelial dysfunction. The implant consists of a human collagen scaffold (support layer) and corneal endothelial cells (drug substance). The product is pre-loaded in a sterile injector/cartridge system that serves as the packaging and transplantation device and is ready for use. It is shipped in corneal storage media and is delivered into the anterior chamber during endothelial keratoplasty.
Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs)
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
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.
Incidence of adverse events (AEs) from 6 to 12 months after PVEK implantation
Number and percentage of participants with any adverse event (AE) .
Elevated IOP
Number and percentage of participants with increased intraocular pressure (IOP) greater than 26 mmHg
BCVA
change from baseline in best corrected visual acuity (BCVA)
Central corneal thickness
Central corneal thickness measurements by OCT
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