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Antisense Oligonucleotide

Open-label Nexagon® (lufepirsen) for Corneal Ulcer (EXPEDE Trial)

Phase 2
Recruiting
Research Sponsored by OcuNexus Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 56 days
Awards & highlights

EXPEDE Trial Summary

This trial will enroll participants who have a corneal injury that hasn't healed after 14 days and will compare Nexagon (lufepirsen) to a placebo. The primary outcome measure is whether the injury heals within 28 days.

EXPEDE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 56 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 56 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment Emergent Adverse Events as assessed by CTCAE v 5.0
The proportion of subjects achieving corneal epithelial recovery, as assessed by slit lamp examination.
Secondary outcome measures
Improvement from baseline of visual acuity measured by the Snellen scale.
The number of NEXAGON treatment doses required to achieve recovery of the corneal epithelium will be assessed.
Time to corneal epithelial recovery, as assessed by slit lamp examination.

EXPEDE Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Nexagon® (lufepirsen) Low Dose ConcentrationExperimental Treatment2 Interventions
Group II: Nexagon® (lufepirsen) High Dose ConcentrationExperimental Treatment2 Interventions
Group III: VehiclePlacebo Group2 Interventions

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Who is running the clinical trial?

OcuNexus Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
747 Total Patients Enrolled
Amber Ophthalmics, Inc.Lead Sponsor
1 Previous Clinical Trials
120 Total Patients Enrolled
~22 spots leftby May 2025
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