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To determine the efficacy and safety of nerve growth factor in the treatment of limbal stem cell deficiency (LSCD) associated with neurotrophic cornea.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cenegermin-Bkbj | Drug | Topical Cenegermin-bkbj 6 times per day for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Size of abnormal epithelium | Change in size of abnormal epithelium compared to baseline | Baseline, week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with resolution of epithelial defect if present prior to treatment | Number of patients with resolution of epithelial defect if present prior to treatment (Stage 2) Mackie Classification of neurotrophic cornea at time of enrollment. | Baseline, week 8 |
| Cornea sensation |
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Inclusion Criteria:
Patients diagnosed with LSCD and neurotrophic cornea confirmed by testing with Cochet-Bonnet aesthesiometer
Exclusion Criteria:
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Adults. Both sexes will be recruited. Any ethnic background, as long as they meet the inclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Christopher N Ta, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36353571 | Derived | Arboleda A, Ta CN. Observational study of cenegermin for the treatment of limbal stem cell deficiency associated with neurotrophic keratopathy. Ther Adv Ophthalmol. 2022 Nov 4;14:25158414221134598. doi: 10.1177/25158414221134598. eCollection 2022 Jan-Dec. |
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| ID | Term |
|---|---|
| C000647429 | cenegermin |
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Cornea sensation measured with Cochet-Bonnet aesthesiometer after treatment compared to screening visit. |
| Baseline, week 8 |