[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617936":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":93,"collaborators":20,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":20,"enrollmentInfo":105,"targetDuration":20,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":117,"overallStatus":76,"whyStopped":20,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Precise Bio","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"PVEK","EXPERIMENTAL","Participants undergo implantation of the PVEK tissue-engineered corneal endothelial implant in a single administration",[13],"Combination Product: Precise Vision Endothelial Keratoplasty (PVEK) Implant",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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\u002Fcartridge 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.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Michael Minouni, Prof.","Rambam Health Care Campus","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Amos Eitan","CONTACT","+972 54 7854387","amos.eitan@precise-bio.com",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Lior Rosenberg Belmaker","+972 52 385 8875","lior.rb@precise-bio.com",[37,54,74],{"facility":38,"status":39,"city":40,"state":20,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Ophthalmological Center After S.V.Malayan","NOT_YET_RECRUITING","Yerevan","0048","Armenia","AM",{"type":45,"coordinates":46},"Point",[47,48],44.5126,40.17765,{"lat":48,"lon":47},[51],{"name":52,"role":29,"phone":20,"phoneExt":20,"email":53},"Lilit Voskanyan, MD","lilit.voskanyan@yahoo.com",{"facility":55,"status":39,"city":56,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Sharei Zedek Medical Center","Jerusalem","abecassis","Israel","IL",{"type":45,"coordinates":61},[62,63],35.21633,31.76904,{"lat":63,"lon":62},[66,70],{"name":67,"role":29,"phone":68,"phoneExt":20,"email":69},"David Zadok, Prof","+972 50 7587348","zadokd@szmc.org.il",{"name":71,"role":29,"phone":72,"phoneExt":20,"email":73},"Hila Givoni","+972 02 6666784","hilag@szmc.org.il",{"facility":75,"status":76,"city":77,"state":20,"zip":78,"country":58,"countryCode":59,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Rambam Medical Center","RECRUITING","Haifa","3109602",{"type":45,"coordinates":80},[81,82],34.99928,32.81303,{"lat":82,"lon":81},[85,89],{"name":86,"role":29,"phone":87,"phoneExt":20,"email":88},"Michael Minouni, Prof","+972 523292429","michael@intername.co.il",{"name":90,"role":29,"phone":91,"phoneExt":20,"email":92},"Meital Abecassis","+972 502061061","m_abecassis@rambam.health.gov.il",{"type":94,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100617936","phase-1-pvek-corneal-implant-for-treatment-of-corneal-edema-100617936",false,"NCT07325097","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","CIFRE","Inclusion Criteria:\n\nage 18\u002F50 years or older\n\nCorneal edema requiring endothelial keratoplasty due to Fuchs' endothelial dystrophy and\u002For pseudophakic bullous keratopathy\n\nPseudophakic study eye\n\nBest corrected visual acuity (BCVA) in the study eye between 6\u002F379 (1.8 logMAR) and 6\u002F12 (0.3 logMAR)\n\nCentral corneal thickness greater than 0.6 mm by OCT\n\nExclusion Criteria:\n\nPhakic study eye\n\nStudy eye is a \"single sight eye\" (per protocol definition) \u002F fellow eye does not meet protocol vision requirement\n\nMalpositioned intraocular lens (dislocation\u002Fsubluxation) in the study eye\n\nPrior ocular procedure in the study eye other than uncomplicated cataract surgery with a stable, centered posterior chamber IOL\n\nAxial length below 21 mm or above 26 mm\n\nOther significant corneal disease (beyond mild dry eye) or prior keratoplasty in the study eye, or visually significant corneal scarring\u002Fopacities not expected to improve with treatment\n\nActive ocular or eyelid infection\u002Finflammation; active\u002Fprior herpetic ocular infection; uveitis\n\nGlaucoma \u002F history or suspicion of elevated IOP, or screening IOP above 23 mmHg (either eye)\n\nSynechiae; abnormal anterior segment (e.g., aphakia, aniridia)\n\nCorneal endothelial cell density above 1000 cells\u002Fmm² at screening (or not reliably measurable)\n\nUncontrolled systemic conditions","ALL","18 Years",{"count":106,"type":107},15,"ESTIMATED","INTERVENTIONAL",[110],"PHASE1","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.\n\nThe main questions it aims to answer are:\n\nWhat side effects may happen after the PVEK implant?\n\nHow 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?\n\nThis 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.\n\nParticipants will:\n\nComplete screening tests (including eye exams and routine health checks)\n\nHave the PVEK implantation surgery\n\nUse prescribed eye drops after surgery\n\nReturn for follow-up visits over the next 12 months for eye exams and tests (such as vision testing, eye pressure checks, and eye scans)",[113,114,115,116],"Corneal Edema","Fuchs' Endothelial Dystrophy","Pseudophakic Bullous Keratopathy","Corneal Endothelial Dysfunction",[118,119,120,121],"Endothelial keratoplasty","Tissue-engineered corneal implant","Corneal endothelial cells","Collagen scaffold","2026-01-08",{"date":124,"type":125},"2026-01-12","ACTUAL",{"date":127,"type":125},"2025-09-16",{"date":129,"type":107},"2027-09",{"name":5,"class":6},3]