PVEK Corneal Implant For Treatment of Corneal Edema

NCT07325097 — Phase 1, Recruiting, 15 participants, Precise Bio

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

Registry	NCT07325097, acronym CIFRE
Status	Recruiting
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	15 (Estimated)
Sponsor	Precise Bio (Industry)
Conditions	Corneal Edema, Fuchs' Endothelial Dystrophy, Pseudophakic Bullous Keratopathy, Corneal Endothelial Dysfunction
Interventions	Precise Vision Endothelial Keratoplasty (PVEK) Implant (Combination product)
Dates	start 2025-09-16, primary completion 2027-03-01 (estimated), completion 2027-09-01 (estimated), first posted 2026-01-08, last updated 2026-01-12
Locations	3 sites in Armenia, Israel

-Summary

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)

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
PVEK	Experimental	Combination Product: Precise Vision Endothelial Keratoplasty (PVEK) Implant	Participants undergo implantation of the PVEK tissue-engineered corneal endothelial implant in a single administration

Precise Vision Endothelial Keratoplasty (PVEK) Implant (Combination product): 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.

+Outcome measures

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.

Secondary outcomes

Incidence of adverse events (AEs) from 6 to 12 months after PVEK implantation [6-12 months]: Number and percentage of participants with any adverse event (AE) .
Elevated IOP [12 months]: Number and percentage of participants with increased intraocular pressure (IOP) greater than 26 mmHg
BCVA [12 months]: change from baseline in best corrected visual acuity (BCVA)
Central corneal thickness [12 months]: Central corneal thickness measurements by OCT
Corneal endothelial cell density [6 and 12 months]: Corneal endothelial cell density assessed by specular microscopy

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

+Locations (3)

Facility	City	Country	Status
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

+Investigators

Michael Minouni, Prof., Principal investigator, Rambam Health Care Campus