Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
15 participants
INTERVENTIONAL
2025-09-16
2027-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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)
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Comparison Between Full Thickness and Partial Thickness Corneal Transplantation for Corneal Edema
NCT00346138
Open-label Prospective Clinical Trial Evaluating the Safety and Efficacy of Biosynthetic CLP-PEG-MPC Corneal Implants in Patients Undergoing High-risk Deep Anterior Lamellar Keratoplasty.
NCT05667337
Descemet Endothelial Thickness Comparison Trial
NCT02373137
Investigation of the Presbia Flexivue Microlens™
NCT02110472
Evaluation of Safety and Efficacy of a Bioengineered Corneal Implant for Treatment of Keratoconus
NCT04653922
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PVEK
Participants undergo implantation of the PVEK tissue-engineered corneal endothelial implant in a single administration
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Precise Bio
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Minouni, Prof.
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ophthalmological Center After S.V.Malayan
Yerevan, , Armenia
Sharei Zedek Medical Center
Jerusalem, Jerusalem, Israel
Rambam Medical Center
Haifa, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CP-CRN-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.