Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04552730
Other study ID # 57888
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04485546 - Study to Evaluate OXERVATEâ„¢ in Patients With Stage 1 Neurotrophic Keratitis Phase 4
Not yet recruiting NCT05927428 - Assessment of the Safety and Efficacy of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis Phase 2
Completed NCT04276558 - REC 0/0559 Eye Drops for Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients Phase 2
Recruiting NCT04573647 - OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate
Completed NCT04820010 - Topical Insulin - Utility and Results in Neurotrophic Keratopathy in Stages 2 and 3
Recruiting NCT04627571 - Corneal Nerves After Treatment With Cenegermin
Enrolling by invitation NCT05758753 - QST for Corneal Nerve Function N/A
Terminated NCT05809245 - Corneal Neurotization as a Treatment for Neurotrophic Keratopathy N/A
Withdrawn NCT05321251 - Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy. Phase 2/Phase 3
Terminated NCT03037450 - Miniinvasive Corneal Neurotization. A Pilot Study. N/A
Not yet recruiting NCT06364657 - Differences in Corneal Structure and Function in Patients With Sjogrens vs. Non-Sjogrens Dry Eye
Recruiting NCT05566717 - An Investigator-Initiated Study to Assess the Association of Diabetic Retinopathy Severity Scale (DRSS) With Level of Decreased Corneal Sensitivity
Not yet recruiting NCT02707120 - Efficacy and Safety of Plasma Rich in Growth Factors (PRGF-Endoret) Eye-drops in the Treatment of Neurotrophic Keratitis Phase 4
Completed NCT01756456 - Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis. Phase 1/Phase 2
Completed NCT02227147 - Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 NK Phase 2
Recruiting NCT05552261 - DEFENDO Long Term Follow-up Study in Stage 1 NK Patients
Recruiting NCT04909450 - Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects Phase 1/Phase 2
Active, not recruiting NCT06411145 - Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis Phase 4