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NCT Number: NCT07325097

PVEK Corneal Implant For Treatment of Corneal Edema

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)

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Key information

Conditions

Corneal Edema Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Corneal Endothelial Dysfunction Eye Diseases Eye Diseases, Hereditary Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn Pseudophakic Bullous Keratopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ophthalmological Center After S.V.Malayan, Yerevan, Armenia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs)

    Time frame: 6 months

    Number and percentage of participants with any adverse event (AE) and any treatment-emergent adverse event (TEAE) occurring after PVEK implantation.

  2. Proportion of participants completing 6-month follow-up without seeking alternative treatment

    Time frame: 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

  1. Incidence of adverse events (AEs) from 6 to 12 months after PVEK implantation

    Time frame: 6-12 months

    Number and percentage of participants with any adverse event (AE) .

  2. Elevated IOP

    Time frame: 12 months

    Number and percentage of participants with increased intraocular pressure (IOP) greater than 26 mmHg

  3. BCVA

    Time frame: 12 months

    change from baseline in best corrected visual acuity (BCVA)

  4. Central corneal thickness

    Time frame: 12 months

    Central corneal thickness measurements by OCT

  5. Corneal endothelial cell density

    Time frame: 6 and 12 months

    Corneal endothelial cell density assessed by specular microscopy

Study contacts

Contact information is provided by the study sponsor or research team.

Amos Eitan

CONTACT

[email protected]

+972 54 7854387

Lior Rosenberg Belmaker

CONTACT

[email protected]

+972 52 385 8875

Sponsors and collaborators

Lead sponsor

Precise Bio

Industry

Registry information

Official study title

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

Acronym: CIFRE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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