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Nerve Growth Factor for the Treatment of Cornea Disease

NCT ID: NCT04552730

Last Updated: 2021-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-14

Study Completion Date

2021-05-04

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neurotrophic Keratitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cenegermin-Bkbj

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

Intervention Type DRUG

Other Intervention Names

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Oxervate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Christopher Ta

Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher N Ta, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36353571 (View on PubMed)

Other Identifiers

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57888

Identifier Type: -

Identifier Source: org_study_id