NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Chemical and/or Thermal Injuries

a study on Corneal Persistent Epithelial Defect

Summary

Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Anthony Aldave, MD (ucla)

Description

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.

Official Title

A Phase 2, Randomized, Prospective, Double-masked, Vehicle-controlled Study to Assess the Efficacy and Safety of Nexagon® (NEXAGON) Applied Topically in Subjects With Corneal Persistent Epithelial Defects Resulting From Severe Ocular Chemical and/or Thermal Injuries

Keywords

Corneal Persistent Epithelial Defect, Nexagon® (lufepirsen) High Dose Concentration, Nexagon® (lufepirsen) Low Dose Concentration, Vehicle, Open-label Nexagon® (lufepirsen)

Eligibility

You can join if…

  1. Male and female of any age.
  2. The presence of a non-infected, corneal persistent epithelial defect (PED) which has resulted 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 from injury.
  4. The PED measures at least 2 mm along the largest diameter at Day 1 of the Treatment Period.
  5. Providing written informed consent and ability to comply with the visit and dosing schedule.

You CAN'T join if...

  1. Subjects who will be unlikely to tolerate the wearing of a Bandage Contact Lens.
  2. Have active ocular infection.
  3. Subjects with corneal perforation or impending corneal perforation.
  4. Subjects with any other past or present ophthalmic disease or medical condition that, in the Investigator's opinion, may affect the safety of the subject or the outcome of the study.
  5. Subjects receiving systemic corticosteroids (equivalent to GREATER THAN 10 mg/day of prednisone) or immunosuppressive or chemotherapeutic agents unless the dose has remained unchanged for 30 days and will remain unchanged during the study.
  6. Subjects being treated with systemic corticosteroids (equivalent to >10 mg/day of prednisone) or immunosuppressive or chemotherapeutic agents unless the dose has remained unchanged for 30 days prior to Day 1.
  7. Subjects with severe lid abnormalities or ocular conditions that contribute to the persistence of the epithelial defect.
  8. Female subjects of childbearing potential who are pregnant, nursing, planning a pregnancy or not using an adequate and medically acceptable form of birth control.
  9. Subjects who have participated in an interventional clinical trial within 30 days prior to Day 1.

Locations

  • Jules Stein Eye Institute accepting new patients
    Los Angeles California 90095 United States
  • Colorado Eye Consultants accepting new patients
    Littleton Colorado 80120 United States

Lead Scientist at University of California Health

  • Anthony Aldave, MD (ucla)
    Dr. Anthony J. Aldave holds the Bartly J. Mondino, M.D., Endowed Chair in Ophthalmology. He previously held the Walton Li Chair in Cornea and Uveitis (4/1/2014 - 6/30/2023).

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amber Ophthalmics, Inc.
ID
NCT04081103
Phase
Phase 2 Corneal Persistent Epithelial Defect Research Study
Study Type
Interventional
Participants
Expecting 108 study participants
Last Updated