Corneal EdemaPhase 1CIFRENCT07325097
PVEK Corneal Implant For Treatment of Corneal Edema
A Phase 1 study testing Precise Vision Endothelial Keratoplasty (PVEK) Implant in people with Corneal Edema and Fuchs' Endothelial Dystrophy, run by Precise Bio at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Edema, Fuchs' Endothelial Dystrophy, Pseudophakic Bullous Keratopathy
- What is being tested?
- Precise Vision Endothelial Keratoplasty (PVEK) Implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 16 Sep 2025to Sep 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Israel2 sites, 2 recruiting
- Recruiting
Rambam Medical Center
Haifa, 3109602
Michael Minouni, Prof, +972 523292429, michael@intername.co.il
Meital Abecassis, +972 502061061, m_abecassis@rambam.health.gov.il
- Not yet recruiting
Sharei Zedek Medical Center
Jerusalem, Jerusalem, abecassis
David Zadok, Prof, +972 50 7587348, zadokd@szmc.org.il
Hila Givoni, +972 02 6666784, hilag@szmc.org.il
Armenia1 site, 1 recruiting
- Not yet recruiting
Ophthalmological Center After S.V.Malayan
Yerevan, 0048
Lilit Voskanyan, MD, lilit.voskanyan@yahoo.com
About this study
Official title: 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:
Read more
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, Fuchs' Endothelial Dystrophy, Pseudophakic Bullous Keratopathy, Corneal Endothelial Dysfunction
- Being tested
- Precise Vision Endothelial Keratoplasty (PVEK) Implant
- Keywords
- Endothelial keratoplasty, Tissue-engineered corneal implant, Corneal endothelial cells, Collagen scaffold
- Medical subject headings
- Corneal Edema, Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precise Vision Endothelial Keratoplasty (PVEK) ImplantCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| PVEK | Experimental | Participants undergo implantation of the PVEK tissue-engineered corneal endothelial implant in a single administration Receives: Combination Product: Precise Vision Endothelial Keratoplasty (PVEK) Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (5)
Incidence of adverse events (AEs) from 6 to 12 months after PVEK implantation
Number and percentage of participants with any adverse event (AE) .
Measured: 6-12 months
Elevated IOP
Number and percentage of participants with increased intraocular pressure (IOP) greater than 26 mmHg
Measured: 12 months
BCVA
change from baseline in best corrected visual acuity (BCVA)
Measured: 12 months
Central corneal thickness
Central corneal thickness measurements by OCT
Measured: 12 months
Corneal endothelial cell density
Corneal endothelial cell density assessed by specular microscopy
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start16 Sep 2025
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- PVEK
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Precise Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Minouni, Prof., Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325097
- Sponsor's protocol ID
- CP-CRN-001
- Acronym
- CIFRE
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be available to other researchers