RecruitingPhase 1NCT07325097

PVEK Corneal Implant For Treatment of Corneal Edema

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

Sponsor

Precise Bio

Enrollment

15 participants

Start Date

Sep 16, 2025

Study Type

INTERVENTIONAL

Conditions

Pseudophakic Bullous Keratopathy Fuchs' Endothelial Dystrophy Corneal Edema Corneal Endothelial Dysfunction

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)

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria11

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

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Interventions

COMBINATION_PRODUCTPrecise 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.