Nerve Growth Factor for the Treatment of Cornea Disease

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04552730
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Actual Duration (Months): 6.6
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurotrophic Keratitis	Drug: Cenegermin-Bkbj

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 5 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Observational Study of Cenegermin-bkbj in the Treatment of Limbal Stem Cell Deficiency Associated With Neurotrophic Keratopathy
• Actual Study Start Date: Oct 14, 2020
• Actual Primary Completion Date: May 4, 2021
• Actual Study Completion Date: May 4, 2021

Outcome Measures

Primary Outcome Measures

1. Size of abnormal epithelium [Baseline, week 8]

   Change in size of abnormal epithelium compared to baseline

Secondary Outcome Measures

1. 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.

2. Cornea sensation [Baseline, week 8]

   Cornea sensation measured with Cochet-Bonnet aesthesiometer after treatment compared to screening visit.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Christopher N Ta, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christopher Ta, Professor of Ophthalmology, Stanford University
• ClinicalTrials.gov Identifier: NCT04552730
• Other Study ID Numbers: 57888
• First Posted: Sep 17, 2020
• Last Update Posted: Dec 14, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Keratitis

Study Results

No Results Posted as of Dec 14, 2021