Nerve Growth Factor for the Treatment of Cornea Disease

Neurotrophic Keratitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04552730
• Other study ID #: 57888
• Status: Completed
• Start date: October 14, 2020
• Est. completion date: May 4, 2021

Study information

• Verified date: December 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 4, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratitis
• Neurotrophic Keratitis

Intervention

Drug:
• Cenegermin-Bkbj
Topical Cenegermin-bkbj 6 times per day for 8 weeks.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Size of abnormal epithelium	Change in size of abnormal epithelium compared to baseline	Baseline, week 8
Secondary	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
Secondary	Cornea sensation	Cornea sensation measured with Cochet-Bonnet aesthesiometer after treatment compared to screening visit.	Baseline, week 8