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Recruiting NCT05966493

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

Phase II Interventional Persistent Corneal Epithelial Defect

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: lufepirsen high dose, Vehicle, lufepirsen low dose.
Who it may be relevant to
Registry conditions: Persistent Corneal Epithelial Defect. Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Germany, Italy, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With Persistent Corneal Epithelial Defects (NEXPEDE-1)

Overview

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.

Detailed 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.

Interventions

  • Drug lufepirsen high dose
    Lufepirsen is an unmodified connexin43 antisense oligonucleotide.
  • Drug Vehicle
    Matching vehicle without lufepirsen.
  • Drug lufepirsen low dose
    Lufepirsen is an unmodified connexin43 antisense oligonucleotide.

Primary outcome measures

  • Achieve Corneal Re-epithelialization Including Durability (CRC) [Time frame: End of Study: 28 Days after achieving re-epithelialization]

Eligibility criteria

Inclusion criteria

  • Have a PCED that is at least 2 weeks in duration and refractory to one or more conventional non-surgical standard of care (SOC) treatments
  • Have no clinical evidence of improvement in the PCED within 2 weeks prior to randomization despite the use of non-surgical SOC treatment
  • Subject must provide written informed consent (or assent)
  • Subjects with childbearing potential must be 1-year postmenopausal, surgically sterilized, or have a negative urine pregnancy test

Exclusion criteria

  • Have a known ocular infection that is deemed to be active requiring therapeutic intervention
  • Present with a corneal surface defect in either eye that is directly attributed to an infectious etiology (bacterial, viral, fungal and/or protozoal) that has not fully resolved and/or treatment has not been completed
  • Present with evidence of corneal ulceration/melting involving the posterior third of the stroma and/or perforation in either eye
  • Have a blepharitis or meibomian gland disease in the study eye that is deemed to be clinically relevant and/or active
  • Have a history of ocular surgery or any ocular procedure(s) not meeting the designated washout time
  • Have any other ocular disease requiring topical ocular medication in the affected eye
  • Have a presence or history of any ocular or systemic disorder or condition that could interfere the safety or efficacy of the study treatment, or the interpretation of the study results
  • Have a known hypersensitivity to one of the components of the study or procedural medications (e.g., NEXAGON, fluorescein)
  • Participated in an interventional clinical drug or device trial within 28 days prior to Day 1
  • Use of the medications presented in the protocol that are prohibited in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 21 centers
  • Glaukos Investigative Site — Dothan
  • Glaukos Investigative Site — Petaluma
  • Glaukos Investigative Site — Torrance
  • Glaukos Investigative Site — Colorado Springs
  • Glaukos Investigative Site — Grand Junction
  • Glaukos Investigative Site — Bradenton
  • Glaukos Investigative Site — Fort Myers
  • Glaukos Investigative Site — South Miami
  • … and 13 more centers
Spain · 4 centers
  • Glaukos Investigative Site — Barcelona
  • Glaukos Investigative Site — Madrid
  • Glaukos Investigative Site — Seville
  • Glaukos Investigative Site — Zaragoza
Germany · 2 centers
  • Glaukos Investigative Site — Mainz
  • Glaukos Investigative Site — München
Italy · 1 center
  • Glaukos investigative Site — Messina

Identifiers

NCT: NCT05966493 · GLK-601-01 (AMB-01-006)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗