PVEK corneal implant to treat corneal swelling
A Prospective, Single Arm Study to Assess the Safety and Tolerability of PVEK Corneal Implant for the Treatment of Corneal Edema
This study will test a PVEK tissue‑engineered corneal implant to see if it is safe and helps people with corneal swelling from Fuchs' endothelial dystrophy or pseudophakic bullous keratopathy who need endothelial keratoplasty.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Precise Bio Industry-sponsored |
| Locations | 3 sites (Yerevan and 2 other locations) |
| Trial ID | NCT07325097 on ClinicalTrials.gov |
What this trial studies
This Phase 1, first‑in‑human, open‑label study will implant a Precise Vision Endothelial Keratoplasty (PVEK) device in about 15 participants with corneal edema due to Fuchs' endothelial dystrophy or pseudophakic bullous keratopathy. All participants receive the PVEK implant (single‑arm) and will use prescribed postoperative eye drops with no placebo or comparator group. The study focuses on safety and tolerability, monitoring side effects and measuring how many participants complete the first six months without needing another treatment. Participants undergo screening, the implantation surgery, and scheduled follow-up visits including eye exams and OCT over a 12‑month period.
Who should consider this trial
Good fit: Ideal candidates are adults with a pseudophakic study eye and corneal edema requiring endothelial keratoplasty due to Fuchs' endothelial dystrophy or pseudophakic bullous keratopathy, with best corrected visual acuity between 6/379 and 6/12 and central corneal thickness greater than 0.6 mm.
Not a fit: Patients unlikely to benefit include those with a phakic study eye, prior keratoplasty or significant corneal scarring, a malpositioned intraocular lens, axial length outside 21–26 mm, active ocular infection or inflammation, or other exclusionary conditions.
Why it matters
Potential benefit: If successful, PVEK could restore corneal clarity and vision while reducing the need for donor corneal tissue.
How similar studies have performed: This is the first‑in‑human trial for PVEK; related tissue‑engineered endothelial implants have shown encouraging preclinical results and very limited early clinical reports but remain largely experimental.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Where this trial is running
Yerevan and 2 other locations
- Ophthalmological Center After S.V.Malayan — Yerevan, Armenia (Not_yet_recruiting)
- Sharei Zedek Medical Center — Jerusalem, Jerusalem, Israel (Not_yet_recruiting)
- Rambam Medical Center — Haifa, Israel (Recruiting)
Study contacts
- Principal investigator: Michael Minouni, Prof. — Rambam Health Care Campus
- Study coordinator: Amos Eitan
- Email: amos.eitan@precise-bio.com
- Phone: +972 54 7854387
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.