NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Chemical and/or Thermal Injuries (EXPEDE)
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
Researchers at OcuNexus Therapeutics, Inc. and Eyevance Pharmaceuticals are recruiting participants for a trial of an ocular injury medication to treat non-infected, corneal persistent epithelial defect (PED) resulting from an ocular chemical and/or thermal ocular injury that has not responded to standard therapy. The investigative therapy, NEXAGON, a therapy using a genetic sequence to inhibit a protein involved in an immune overreaction that prevents corneal healing. Researchers believe that inhibiting that overreaction with promote regeneration of the corneal epithelium.
NEXAGON is administered to the eye and held in place with a bandage contact. Participants who meet criteria will be given one of two dose levels of the drug, or a placebo for comparison.
- Have 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, non-responsive to current standard of care for at least 14 days from injury, which measures at least 2 mm along the largest diameter.
- Must not have active ocular infection.
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility and safety of the patient to participate.
- Administration of the tropical drug under a contact bandage, on multiple days over a 28-day period.
- Follow up at 28 and 56 days post treatment.
LOCATIONS AND CONTACTS:
Your doctor may contact study contacts to determine locations and eligibility.
Contact: Brian Levy, OD, MSc | +1 (585) 978 1943 | [email protected]
Contact: Mark C Jasek, PhD | +1 (817) 677 6127 | [email protected]
OcuNexus Therapeutics, Inc.
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