NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Injuries

Last updated: October 21, 2024
Sponsor: Amber Ophthalmics, Inc.
Overall Status: Terminated

Phase

2

Condition

N/A

Treatment

Vehicle

Open-label Nexagon® (lufepirsen)

Nexagon® (lufepirsen) High Dose Concentration

Clinical Study ID

NCT04081103
NEX-PED-005
  • All Genders

Study Summary

This study will enroll participants with a non-infected, corneal persistent epithelial defect (PED) resulting from an ocular chemical and/or thermal ocular injury which is non-responsive or refractory to current standard of care for at least 14 days. It will assess the efficacy and safety of Nexagon® (lufepirsen) plus standard of care versus NEXAGON-vehicle (placebo) plus standard of care. The recovery of the corneal epithelium will be the primary outcome measure, defined as a cornea that re-epithelializes by Day 28 of treatment and remains re-epithelialized for at least a further 28 days.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male and female of any age.

  2. The presence of a non-infected, corneal persistent epithelial defect (PED) which hasresulted from a severe chemical and/or thermal (burn) injury to one or both eyes.

  3. The PED is non-responsive to current standard of care for at least 14 days frominjury.

  4. The PED measures at least 2 mm along the largest diameter at Day 1 of the TreatmentPeriod.

  5. Providing written informed consent and ability to comply with the visit and dosingschedule.

Exclusion

Exclusion Criteria:

  1. Have active ocular infection.

  2. Subjects with corneal perforation or impending corneal perforation.

  3. Subjects with any other past or present ophthalmic disease or medical conditionthat, in the Investigator's opinion, may affect the safety of the subject or theoutcome of the study.

  4. Subjects with severe lid abnormalities or ocular conditions that contribute to thepersistence of the epithelial defect.

  5. Female subjects of childbearing potential who are pregnant, nursing, planning apregnancy or not using an adequate and medically acceptable form of birth control.

  6. Subjects who have participated in an interventional clinical trial within 30 daysprior to Day 1.

Study Design

Total Participants: 35
Treatment Group(s): 4
Primary Treatment: Vehicle
Phase: 2
Study Start date:
June 30, 2020
Estimated Completion Date:
February 07, 2022

Connect with a study center

  • Jules Stein Eye Institute

    Los Angeles, California 90095
    United States

    Site Not Available

  • Colorado Eye Consultants

    Littleton, Colorado 80120
    United States

    Site Not Available

  • Cincinnati Eye Institute

    Edgewood, Kentucky 41017
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mercy Eye Care

    Springfield, Missouri 65804
    United States

    Site Not Available

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