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
- Are there results?
- Not yet: the study is under way
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
Show all 11Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm Study to Assess the Safety and Tolerability of PVEK Corneal Implant for the Treatment of Corneal Edema
- ClinicalTrials.gov ID
- NCT07325097
- Acronym / sponsor ID
- CIFRE / CP-CRN-001
- Conditions
- Corneal Edema, Fuchs' Endothelial Dystrophy, Pseudophakic Bullous Keratopathy, Corneal Endothelial Dysfunction
- Keywords
- Endothelial keratoplasty, Tissue-engineered corneal implant, Corneal endothelial cells, Collagen scaffold
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Precise BioIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PVEK
| Arm | Type | Receives |
|---|---|---|
| PVEK | Experimental | Combination Product: Precise Vision Endothelial Keratoplasty (PVEK) ImplantParticipants undergo implantation of the PVEK tissue-engineered corneal endothelial implant in a single administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Precise Vision Endothelial Keratoplasty (PVEK) ImplantPVEK 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. | Combination product | PVEK |
Primary outcome
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.
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.
5 secondary outcomes
Incidence of adverse events (AEs) from 6 to 12 months after PVEK implantation
Time frame: 6-12 months
Elevated IOP
Time frame: 12 months
BCVA
Time frame: 12 months
Central corneal thickness
Time frame: 12 months
Corneal endothelial cell density
Time frame: 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No. No individual participant data will be available to other researchers
Related trials for Corneal Edema
RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
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Active, not recruitingPhase 3
AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Corneal Endothelial Dysfunction
Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
Corneal Edema, Corneal Endothelial Disorder
Enrolling by invitationObservational study
The Effect of Topical Rho-kinase Inhibitors on Corneas of Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Cataract
Recruiting
Plasma Rich in Growth Factors in Corneal Endothelial Transplantation
Fuchs' Endothelial Dystrophy, Corneal Edema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Minouni, Prof. principal investigator
Rambam Health Care Campus
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel, Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amos Eitan (+972 54 7854387, amos.eitan@precise-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.