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Completed

NCT Number: NCT04552730

Nerve Growth Factor for the Treatment of Cornea Disease

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

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Key information

Conditions

Neurotrophic Keratitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients diagnosed with LSCD and neurotrophic cornea confirmed by testing with Cochet-Bonnet aesthesiometer

Exclusion criteria

  • Active ocular infection
  • Anticipated need for bandage contact lens, amniotic membrane graft, or tarsorrhaphy during the study period
  • Unable to discontinue the use of contact lens
  • Visual acuity worse than 20/200 in the better eye

Treatment and study plan

cenegermin-bkbj

Drug

Topical Cenegermin-bkbj 6 times per day for 8 weeks.

Other names: Oxervate

Primary outcomes

  1. Size of abnormal epithelium

    Time frame: Baseline, week 8

    Change in size of abnormal epithelium compared to baseline

Secondary outcomes

  1. Number of patients with resolution of epithelial defect if present prior to treatment

    Time frame: 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

    Time frame: Baseline, week 8

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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 17, 2020
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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