Neurotrophic Keratitis
Conditions
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.
Interventions
DRUGCenegermin-Bkbj
Topical Cenegermin-bkbj 6 times per day for 8 weeks.
Sponsors
Stanford University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients diagnosed with LSCD and neurotrophic cornea confirmed by testing with Cochet-Bonnet aesthesiometer
Exclusion criteria
1. Active ocular infection 2. Anticipated need for bandage contact lens, amniotic membrane graft, or tarsorrhaphy during the study period 3. Unable to discontinue the use of contact lens 4. Visual acuity worse than 20/200 in the better eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Size of abnormal epithelium | Baseline, week 8 | Change in size of abnormal epithelium compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Cornea sensation | Baseline, week 8 | Cornea sensation measured with Cochet-Bonnet aesthesiometer after treatment compared to screening visit. |
Countries
United States
Outcome results
None listed