A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Phase 2/3 Study to Evaluate the Safety and Efficacy of NEXAGON (Lufepirsen Ophthalmic Gel) in Subjects with Persistent Corneal Epithelial Defects (NEXPEDE-1)
- Sponsor: Amber Ophthalmics, Inc.
- Principal Investigator: Evan Warner, MD
- Study Coordinator: Chris Smith
Study Objective:
To evaluate the safety and efficacy of NEXAGON (lufepirsen ophthalmic gel) in subjects with persistent corneal epithelial defects (PCED).
Study Design:
Randomized subjects in this study will receive topical treatment with NEXAGON 0.06%, NEXAGON 0.006% or vehicle (1:1:1) in the clinic on Days 1, 2, 8, 15, and 22. Subjects not achieving corneal re-epithelialization on Day 29 will receive weekly administrations until re-epithelialization occurs, or have reached Day 57 without re-epithelialization.
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
- PCED measures at least 2 mm along the largest diameter
- 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 in the opinion of the Investigator is deemed to be clinically relevant and/or active
- Have a history of a full thickness keratoplasty, > 1 Descemet membrane endothelial keratoplasty (DMEK) or Descemet’s stripping endothelial keratoplasty (DSEK) procedure
- Have any other ocular disease requiring topical ocular medication in the affected eye
- A Schirmer I test result (without anesthesia) of ≤ 3 mm/5 minutes in the study eye
- Have a known hypersensitivity to one of the components of the study or procedural medications (e.g., NEXAGON, fluorescein)
- Use of Oxervate within 30 days of study enrollment.
Contact Chris Smith with questions, (608) 263-7169
For more information about this study, visit clinicaltrials.gov: https://classic.clinicaltrials.gov/ct2/show/NCT05966493?term=A+Randomized%2C+Multicenter%2C+Double-Masked%2C+Vehicle+-Controlled+Phase+2%2F3+Study+to+Evaluate+the+Safety+and+Efficacy+of+NEXAGON%C2%AE+%28Lufepirsen+Ophthalmic+Gel%29+in+Subjects+with+Persistent+Corneal+Epithelial+Defects+%28NEXPEDE-1%29&draw=2&rank=1