Actively Recruiting
A Prospective, Single Arm Study to Assess the Safety and Tolerability of PVEK Corneal Implant for the Treatment of Corneal Edema
Led by Precise Bio · Updated on 2026-01-12
15
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of PVEK, a tissue-engineered corneal implant, for people with corneal swelling caused by Fuchs' endothelial dystrophy or pseudophakic bullous keratopathy who need endothelial keratoplasty. This Phase 1 study aims to identify possible side effects after the implant and how many participants can complete 6 months after surgery without needing another treatment due to implant intolerance or ineffectiveness. About 15 participants will be involved and followed for up to 12 months after surgery. Participants will undergo implantation of the PVEK corneal endothelial implant in a single surgery. The implant combines a human collagen scaffold and corneal endothelial cells and is delivered into the eye during endothelial keratoplasty using a sterile injector system. After surgery, participants will use prescribed eye drops and attend scheduled follow-up visits for up to 12 months to monitor eye health and implant performance. During the study, participants will complete initial screening including eye exams and health checks before implantation. Follow-up visits will include vision tests, eye pressure measurements, and eye scans to assess corneal thickness and endothelial cell density. Researchers will track the incidence of adverse events for 12 months, monitor eye pressure, and evaluate visual acuity and corneal health. The main outcomes focus on safety and implant tolerability during the first 6 months and continued monitoring up to one year.
CONDITIONS
Brief Title
PVEK Corneal Implant For Treatment of Corneal Edema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 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 will not qualify if you...
- Phakic study eye
- Study eye is a "single sight eye" or fellow eye does not meet vision requirements
- Malpositioned intraocular lens (dislocation or subluxation) in the study eye
- Prior ocular procedures other than uncomplicated cataract surgery with 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
- Visually significant corneal scarring or opacities not expected to improve with treatment
- Active ocular or eyelid infection or inflammation; active or prior herpetic ocular infection; uveitis
- Glaucoma or history/suspicion of elevated intraocular pressure; screening IOP above 23 mmHg in either eye
- Synechiae or abnormal anterior segment conditions (e.g., aphakia, aniridia)
- Corneal endothelial cell density above 1000 cells/mm² at screening or not reliably measurable
- Uncontrolled systemic conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single administration with follow-up to 12 months
Participants undergo implantation of the PVEK tissue-engineered corneal endothelial implant in a single administration.
Multiple visits over 12 months for monitoring and assessments
Trial Site Locations
Total: 3 locations
1
Ophthalmological Center After S.V.Malayan
Yerevan, Armenia, 0048
Not Yet Recruiting
2
Sharei Zedek Medical Center
Jerusalem, Jerusalem, Israel, abecassis
Not Yet Recruiting
3
Rambam Medical Center
Haifa, Israel, 3109602
Actively Recruiting
Research Team
A
Amos Eitan
L
Lior Rosenberg Belmaker
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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