Corneal Edema, Corneal Endothelial Dysfunction, Fuchs' Endothelial Dystrophy, Pseudophakic Bullous Keratopathy
Conditions
Keywords
Endothelial keratoplasty, Tissue-engineered corneal implant, Corneal endothelial cells, Collagen scaffold
Brief 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. 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)
Interventions
COMBINATION_PRODUCTPrecise 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.
Sponsors
Precise Bio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
PVEK
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BCVA | 12 months | change from baseline in best corrected visual acuity (BCVA) |
| Incidence of adverse events (AEs) from 6 to 12 months after PVEK implantation | 6-12 months | Number and percentage of participants with any adverse event (AE) . |
| Corneal endothelial cell density | 6 and 12 months | Corneal endothelial cell density assessed by specular microscopy |
| Central corneal thickness | 12 months | Central corneal thickness measurements by OCT |
| Elevated IOP | 12 months | Number and percentage of participants with increased intraocular pressure (IOP) greater than 26 mmHg |
Countries
Armenia, Israel
Contacts
Primary ContactAmos Eitan
Backup ContactLior Rosenberg Belmaker
Outcome results
None listed