PVEK Corneal Implant For Treatment of Corneal Edema

NCT07325097 | Recruiting Phase 1

• 1 other identifier: CP-CRN-001
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 3

Brief 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)

Conditions

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

Keywords

Endothelial keratoplasty; Tissue-engineered corneal implant; Corneal endothelial cells; Collagen scaffold

Outcome Measures

Primary Outcomes (2)

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

  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

  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 Outcomes (5)

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

  6-12 months

• Elevated IOP

  12 months

• BCVA

  12 months

• Central corneal thickness

  12 months

• Corneal endothelial cell density

  6 and 12 months

Study Arms (1)

PVEK

EXPERIMENTAL

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

Combination Product: Precise Vision Endothelial Keratoplasty (PVEK) Implant

Interventions

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.

PVEK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Precise Bio: lead

Study Sites (3)

Ophthalmological Center After S.V.Malayan

Yerevan, 0048, Armenia

NOT YET RECRUITING

Sharei Zedek Medical Center

Jerusalem, Jerusalem, abecassis, Israel

NOT YET RECRUITING

Rambam Medical Center

Haifa, 3109602, Israel

RECRUITING

MeSH Terms

Conditions

Corneal Edema; Fuchs' Endothelial Dystrophy

Interventions

Drug Implants

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Corneal Dystrophies, Hereditary; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Michael Minouni, Prof.

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amos Eitan

CONTACT

+972 54 7854387; amos.eitan@precise-bio.com

Lior Rosenberg Belmaker

CONTACT

+972 52 385 8875; lior.rb@precise-bio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: PVEK

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 8, 2026
• Study Start: September 16, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1); IL (2)