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First in Human (FIH) Study to Assess Safety and Efficacy of the CorNeat KPro for the Treatment of Corneal Blindness
NA trial testing CorNeat KPro in Corneal Disease in 10 participants. Terminated before completion.
| Lead sponsor | CorNeat Vision Ltd. |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 3 January 2021 |
| Primary completion | 1 June 2023 |
| Estimated completion | 1 June 2023 |
| Sites | 8 locations across France, Netherlands, Israel, Canada, United States |
CorNeat Vision Ltd.
Adults 18 to 80, any sex, with Corneal Disease or Corneal Opacity. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The frequency and severity of all unanticipated adverse device-related events (UADE) or treatment-related adverse events, during and after implantation of the CorNeat KPro and up to 12 months should be less than SOC
| Group | Value | 95% CI |
|---|---|---|
| CorNeat KPro | 7 |
Improvement in BCDVA (using ETDRS visual acuity chart, where applicable) compared to baseline
| Group | Value | 95% CI |
|---|---|---|
| CorNeat KPro | 8 |
Time frame: 2 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | CorNeat KPro |
|---|---|---|
| Covid 19 Infection | Infections and infestations | — |
| Exposure of implant | Eye disorders | — |
| Flat AC with bleeding | Eye disorders | — |
| Fungal infection in the skirt of artificial cornea | Eye disorders | — |
| Headache | General disorders | — |
| Shallow retinal detachment | Eye disorders | — |
| Dehiscence of prosthesis superiorly | Eye disorders | — |
| Conjunctival retraction with dehiscence of prosthesis & possible corneal epithelial ingrowth | Eye disorders | — |
| Choroidal detachment and exudative detachment | Eye disorders | — |
| Reaction | System | CorNeat KPro |
|---|---|---|
| Exposed synthetic skirt of the implant | Eye disorders | — |
| Severe headache (crown top right) | General disorders | — |
| Choroidal Hemorrhage | Eye disorders | — |
| Vitreous Hemorrhage | Eye disorders | — |
| Metabolic acidosis | Eye disorders | — |
| Retro prosthetic membrane | Eye disorders | — |
| White nodule on the prosthetic skirt | Eye disorders | — |
| left eye ocular pain | Eye disorders | — |
| fungal infection in the skirt of cornet artificial cornea | Eye disorders | — |
| abnormal serum enzyme levels | Eye disorders | — |
| elevated IOP | Eye disorders | — |
| eye pain | Eye disorders | — |
| watery eye | Eye disorders | — |
| Light sensitivity | Eye disorders | — |
| nausea, body rash | General disorders | — |
| Pain around eye | Eye disorders | — |
| Shallow retinal detachment | Eye disorders | — |
| Hyphema | Eye disorders | — |
| Patient had vitrectomy, with PRP laser and Avastin injections done on July 28th due to the non-resol | Eye disorders | — |
| Dehiscence of prosthesis superiorly due to retraction | Eye disorders | — |
| Conjunctival retraction with dehiscence of prosthesis & possible corneal epithelial ingrowth | Eye disorders | — |
| During sep. of iris from cornea bleeding began & didnt allow surgeon to place device in good conditi | Eye disorders | — |
| Conjunctival retraction | Eye disorders | — |
| Disjunction of the nasal part of the KPRO | Eye disorders | — |
| Choroidal detachment and exudative detachment | Eye disorders | — |
Most-reported serious reactions: Covid 19 Infection, Exposure of implant, Flat AC with bleeding, Fungal infection in the skirt of artificial cornea, Headache, Shallow retinal detachment, Dehiscence of prosthesis superiorly, Conjunctival retraction with dehiscence of prosthesis & possible corneal epithelial ingrowth.
Data from ClinicalTrials.gov NCT04485858 adverse events section.
Prospective, open label, single arm, First in Human (FIH) clinical study to assess safety and efficacy of the CorNeat Keratoprosthesis, a synthetic cornea, for the treatment of corneal blindness
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04485858.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing