Nerve Growth Factor for the Treatment of Cornea Disease
- Conditions
- Neurotrophic Keratitis
- Registration Number
- NCT04552730
- Lead Sponsor
- Stanford University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
Patients diagnosed with LSCD and neurotrophic cornea confirmed by testing with Cochet-Bonnet aesthesiometer
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Size of abnormal epithelium Baseline, week 8 Change in size of abnormal epithelium compared to baseline
- Secondary Outcome Measures
Name Time Method Cornea sensation Baseline, week 8 Cornea sensation measured with Cochet-Bonnet aesthesiometer after treatment compared to screening visit.
Number of patients with resolution of epithelial defect if present prior to treatment Baseline, week 8 Number of patients with resolution of epithelial defect if present prior to treatment (Stage 2) Mackie Classification of neurotrophic cornea at time of enrollment.
Trial Locations
- Locations (1)
Stanford University
🇺🇸Stanford, California, United States