PVEK Corneal Implant For Treatment of Corneal Edema (CIFRE)

Precise Bio

Status and phase: Enrolling; Phase 1

Conditions: Corneal Edema; Fuchs' Endothelial Dystrophy; Corneal Endothelial Dysfunction; Pseudophakic Bullous Keratopathy

Treatments: Combination Product: Precise Vision Endothelial Keratoplasty (PVEK) Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT07325097

CP-CRN-001

Details and patient eligibility

About

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)

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

PVEK

Experimental group

Description:

Participants undergo implantation of the PVEK tissue-engineered corneal endothelial implant in a single administration

Treatment:

Combination Product: Precise Vision Endothelial Keratoplasty (PVEK) Implant