A Phase 1 interventional study of Precise Vision Endothelial Keratoplasty (PVEK) Implant in Corneal Edema, Fuchs' Endothelial Dystrophy and Pseudophakic Bullous Keratopathy, sponsored by Precise Bio. Recruiting at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by Precise Bio · Phase 1, Interventional, and Treatment
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)
39 studies on the registry are indexed under Corneal Edema; 8 are open to participants now.
This study's planned enrollment of 15 is below the median of 52 across 31 interventional studies indexed under Corneal Edema.
Browse Corneal Edema studies →This is the only study on the registry with Precise Bio as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
age 18/50 years or older
Corneal edema requiring endothelial keratoplasty due to Fuchs' endothelial dystrophy and/or pseudophakic bullous keratopathy
Pseudophakic study eye
Best corrected visual acuity (BCVA) in the study eye between 6/379 (1.8 logMAR) and 6/12 (0.3 logMAR)
Central corneal thickness greater than 0.6 mm by OCT
Exclusion Criteria:
Phakic study eye
Study eye is a "single sight eye" (per protocol definition) / fellow eye does not meet protocol vision requirement
Malpositioned intraocular lens (dislocation/subluxation) in the study eye
Prior ocular procedure in the study eye other than uncomplicated cataract surgery with a stable, centered posterior chamber IOL
Axial length below 21 mm or above 26 mm
Other significant corneal disease (beyond mild dry eye) or prior keratoplasty in the study eye, or visually significant corneal scarring/opacities not expected to improve with treatment
Active ocular or eyelid infection/inflammation; active/prior herpetic ocular infection; uveitis
Glaucoma / history or suspicion of elevated IOP, or screening IOP above 23 mmHg (either eye)
Synechiae; abnormal anterior segment (e.g., aphakia, aniridia)
Corneal endothelial cell density above 1000 cells/mm² at screening (or not reliably measurable)
Uncontrolled systemic conditions
Participants undergo implantation of the PVEK tissue-engineered corneal endothelial implant in a single administration
Combination Product: Precise Vision Endothelial Keratoplasty (PVEK) Implant
PVEK 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.
Time frame: 6 months
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.
Time frame: 6 months
Incidence of adverse events (AEs) from 6 to 12 months after PVEK implantation
Number and percentage of participants with any adverse event (AE) .
Time frame: 6-12 months
Elevated IOP
Number and percentage of participants with increased intraocular pressure (IOP) greater than 26 mmHg
Time frame: 12 months
BCVA
change from baseline in best corrected visual acuity (BCVA)
Time frame: 12 months
Central corneal thickness
Central corneal thickness measurements by OCT
Time frame: 12 months
Corneal endothelial cell density
Corneal endothelial cell density assessed by specular microscopy
Time frame: 6 and 12 months
Plan to share: No — No individual participant data will be available to other researchers
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