Observational Study of Cenegermin-bkbj in the Treatment of Limbal Stem Cell Deficiency Associated With Neurotrophic Keratopathy

Stanford University1 site in 1 country5 target enrollmentOctober 14, 2020

ConditionsNeurotrophic Keratitis

DrugsCenegermin-Bkbj

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neurotrophic Keratitis
Sponsor: Stanford University
Enrollment: 5
Locations: 1
Primary Endpoint: Size of abnormal epithelium
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To determine the efficacy and safety of nerve growth factor in the treatment of limbal stem cell deficiency (LSCD) associated with neurotrophic cornea.

Detailed Description

This is a prospective open-label pilot study evaluating the role of cenegermin-bkbj for the treatment of LSCD with associated neurotrophic keratopathy. Patient diagnosed with LSCD with neurotrophic cornea who have failed conventional treatment such as artificial tears are enrolled in the study after a 2 week washout period. Patient are then treated with cenegermin-bkbj over an 8 week period.

Registry

clinicaltrials.gov

Start Date

October 14, 2020

End Date

May 4, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Stanford University

Responsible Party

Principal Investigator

Christopher Ta

Professor of Ophthalmology

Stanford University

Eligibility Criteria

Inclusion Criteria

•Patients diagnosed with LSCD and neurotrophic cornea confirmed by testing with Cochet-Bonnet aesthesiometer

Exclusion Criteria

•Active ocular infection
•Anticipated need for bandage contact lens, amniotic membrane graft, or tarsorrhaphy during the study period
•Unable to discontinue the use of contact lens
•Visual acuity worse than 20/200 in the better eye