NCT04552730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

October 14, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2021

Completed
Last Updated

December 14, 2021

Status Verified

December 1, 2021

Enrollment Period

7 months

First QC Date

September 11, 2020

Last Update Submit

December 10, 2021

Conditions

Neurotrophic Keratitis

Outcome Measures

Primary Outcomes (1)

  • Size of abnormal epithelium

    Change in size of abnormal epithelium compared to baseline

    Baseline, week 8

Secondary Outcomes (2)

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

    Baseline, week 8

  • Cornea sensation

    Baseline, week 8

Interventions

Cenegermin-BkbjDRUG

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

Also known as: Oxervate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults. Both sexes will be recruited. Any ethnic background, as long as they meet the inclusion criteria.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

  • 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.

    PMID: 36353571DERIVED

MeSH Terms

Interventions

cenegermin

Study Officials

  • Christopher N Ta, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Ophthalmology

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 17, 2020

Study Start

October 14, 2020

Primary Completion

May 4, 2021

Study Completion

May 4, 2021

Last Updated

December 14, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)