A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED

Last updated: July 30, 2024
Sponsor: Amber Ophthalmics, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Vehicle

lufepirsen

Clinical Study ID

NCT05966493
GLK-601-001 (AMB-01-006)
  • Ages > 2
  • All Genders

Study Summary

This study is to evaluate the safety and efficacy of NEXAGON® (lufepirsen ophthalmic gel) (NEXAGON) in subjects with persistent corneal epithelial defects (PCED). The objectives of the study are to evaluate the safety and efficacy of NEXAGON in this population.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Have a PCED that is at least 2 weeks in duration and refractory to one or moreconventional non-surgical standard of care (SOC) treatments

  2. Have no clinical evidence of improvement in the PCED within 2 weeks prior torandomization despite the use of non-surgical SOC treatment

  3. Subject must provide written informed consent (or assent)

  4. Subjects with childbearing potential must be 1-year postmenopausal, surgicallysterilized, or have a negative urine pregnancy test

Exclusion

Exclusion Criteria:

  1. Have a known ocular infection that is deemed to be active requiring therapeuticintervention

  2. Present with a corneal surface defect in either eye that is directly attributed toan infectious etiology (bacterial, viral, fungal and/or protozoal) that has notfully resolved and/or treatment has not been completed

  3. Present with evidence of corneal ulceration/melting involving the posterior third ofthe stroma and/or perforation in either eye

  4. Have a blepharitis or meibomian gland disease in the study eye that is deemed to beclinically relevant and/or active

  5. Have a history of ocular surgery or any ocular procedure(s) not meeting thedesignated washout time

  6. Have any other ocular disease requiring topical ocular medication in the affectedeye

  7. Have a presence or history of any ocular or systemic disorder or condition thatcould interfere the safety or efficacy of the study treatment, or the interpretationof the study results

  8. Have a known hypersensitivity to one of the components of the study or proceduralmedications (e.g., NEXAGON, fluorescein)

  9. Participated in an interventional clinical drug or device trial within 28 days priorto Day 1

  10. Use of the medications presented in the protocol that are prohibited in the study.

Study Design

Total Participants: 84
Treatment Group(s): 2
Primary Treatment: Vehicle
Phase: 2
Study Start date:
August 17, 2023
Estimated Completion Date:
December 31, 2025

Study Description

This study is a randomized, multicenter, double-masked, vehicle-controlled study to evaluate the safety and efficacy of NEXAGON (lufepirsen ophthalmic gel) in subjects with persistent corneal epithelial defects (PCED). The study will enroll subjects who will complete a Screening Period, Treatment Period (up to 8 weeks) and Follow-up Period (4 weeks). Those subjects whose defect has not re-epithelialized by the completion of the Treatment Period or who achieved re-epithelialization but failed to maintain re-epithelialization for 28 days after treatment completion (durability) are eligible to enter the NEXAGON Open-label Treatment Period for an additional 8 weeks.

Connect with a study center

  • Principal Investigator

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • Principal Investigator

    Pasadena, California 91107
    United States

    Site Not Available

  • Principal Investigator

    Torrance, California 90505
    United States

    Site Not Available

  • Principal Investigator

    Grand Junction, Colorado 81501
    United States

    Site Not Available

  • Principal Investigator

    Atlanta, Georgia 30339
    United States

    Site Not Available

  • Principal Investigator

    Nashville, Tennessee 37215
    United States

    Site Not Available

  • Principal Investigator

    San Antonio, Texas 78238
    United States

    Site Not Available

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