PVEK Corneal Implant For Treatment of Corneal Edema (CIFRE)

January 8, 2026 updated by: Precise Bio

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Armenia
      • Yerevan, Armenia, 0048
  • Israel
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, abecassis
        • Not yet recruiting
        • Sharei Zedek Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PVEK
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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) .
6-12 months
Elevated IOP
Time Frame: 12 months
Number and percentage of participants with increased intraocular pressure (IOP) greater than 26 mmHg
12 months
BCVA
Time Frame: 12 months
change from baseline in best corrected visual acuity (BCVA)
12 months
Central corneal thickness
Time Frame: 12 months
Central corneal thickness measurements by OCT
12 months
Corneal endothelial cell density
Time Frame: 6 and 12 months
Corneal endothelial cell density assessed by specular microscopy
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Precise Bio

Investigators

  • Principal Investigator: Michael Minouni, Prof., Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

December 22, 2025

First Posted (Estimated)

January 8, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-CRN-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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