Trials / Recruiting
RecruitingNCT07325097
PVEK Corneal Implant For Treatment of Corneal Edema
A Prospective, Single Arm Study to Assess the Safety and Tolerability of PVEK Corneal Implant for the Treatment of Corneal Edema
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Precise Bio · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Conditions
- Corneal Edema
- Fuchs' Endothelial Dystrophy
- Pseudophakic Bullous Keratopathy
- Corneal Endothelial Dysfunction
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | 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. |
Timeline
- Start date
- 2025-09-16
- Primary completion
- 2027-03-01
- Completion
- 2027-09-01
- First posted
- 2026-01-08
- Last updated
- 2026-01-12
Locations
3 sites across 2 countries: Armenia, Israel
Source: ClinicalTrials.gov record NCT07325097. Inclusion in this directory is not an endorsement.