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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 56 days

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

Do I qualify?Apply below to find out

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent has Open-label Nexagon® (lufepirsen) been utilized in experimental studies?

"As of now, one clinical trial is being conducted examining the efficacy and safety of Open-label Nexagon® (lufepirsen). None are in their third phase. Whilst most research for this medication is based in Edgewood, Kentucky, there are 6 other sites that also have ongoing studies."

Answered by AI

How many geographic locations is this research initiative active in?

"This research project is operating at the Jules Stein Eye Institute in Los Angeles, California; Colorado Eye Consultants in Littleton, Colorado; and University of Minnesota in Minneapolis, as well as 6 additional sites."

Answered by AI

Does this investigation break any new ground?

"In 2020, OcuNexus Therapeutics, Inc. initiated a clinical trial for open-label Nexagon® (lufepirsen) which involved 108 patients. Subsequently, this medication achieved Phase 2 drug approval and today there is an active ongoing study sponsored by the same company."

Answered by AI

How many individuals are actively enrolled in this experiment?

"This medical research necessitates the participation of 108 qualified individuals. Those interested can be evaluated at either Jules Stein Eye Institute in LA, or Colorado Eye Consultants located in Littleton."

Answered by AI

Are there currently opportunities for individuals to partake in the trial?

"Affirmative, clinicaltrials.gov affirms that this medical trial has been actively recruiting since June 30th 2020 and was last amended on August 25th 2022. The desired number of patients is 108 to be sourced from 6 different sites."

Answered by AI

Is Open-label Nexagon® (lufepirsen) an officially sanctioned treatment method?

"As a Phase 2 trial lacking evidence for efficacy, Open-label Nexagon® (lufepirsen) was assigned the score of 2 to represent its relative safety profile."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Chemical and/or Thermal Injuries

2020. "NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Chemical and/or Thermal Injuries". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04081103.