NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Injuries (EXPEDE)

Glaukos

Status and phase: Terminated; Phase 2

Conditions: Corneal Persistent Epithelial Defect

Treatments: Drug: Nexagon® (lufepirsen) High Dose Concentration; Drug: Vehicle; Drug: Open-label Nexagon® (lufepirsen); Drug: Nexagon® (lufepirsen) Low Dose Concentration

Study type: Interventional

Funder types: Industry

Identifiers

NCT04081103

NEX-PED-005

Details and patient eligibility

About

This study will enroll participants with a non-infected, corneal persistent epithelial defect (PED) resulting from an ocular chemical and/or thermal ocular injury which is non-responsive or refractory to current standard of care for at least 14 days. It will assess the efficacy and safety of Nexagon® (lufepirsen) plus standard of care versus NEXAGON-vehicle (placebo) plus standard of care. The recovery of the corneal epithelium will be the primary outcome measure, defined as a cornea that re-epithelializes by Day 28 of treatment and remains re-epithelialized for at least a further 28 days.

Enrollment: 35 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female of any age.
2. The presence of a non-infected, corneal persistent epithelial defect (PED) which has resulted from a severe chemical and/or thermal (burn) injury to one or both eyes.
3. The PED is non-responsive to current standard of care for at least 14 days from injury.
4. The PED measures at least 2 mm along the largest diameter at Day 1 of the Treatment Period.
5. Providing written informed consent and ability to comply with the visit and dosing schedule.

Exclusion criteria

1. Have active ocular infection.
2. Subjects with corneal perforation or impending corneal perforation.
3. Subjects with any other past or present ophthalmic disease or medical condition that, in the Investigator's opinion, may affect the safety of the subject or the outcome of the study.
4. Subjects with severe lid abnormalities or ocular conditions that contribute to the persistence of the epithelial defect.
5. Female subjects of childbearing potential who are pregnant, nursing, planning a pregnancy or not using an adequate and medically acceptable form of birth control.
6. Subjects who have participated in an interventional clinical trial within 30 days prior to Day 1.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 3 patient groups, including a placebo group

Nexagon® (lufepirsen) High Dose Concentration

Experimental group

Treatment:

Drug: Open-label Nexagon® (lufepirsen)

Drug: Nexagon® (lufepirsen) High Dose Concentration

Nexagon® (lufepirsen) Low Dose Concentration

Experimental group

Treatment:

Drug: Nexagon® (lufepirsen) Low Dose Concentration

Drug: Open-label Nexagon® (lufepirsen)

Vehicle

Placebo Comparator group

Treatment:

Drug: Open-label Nexagon® (lufepirsen)

Drug: Vehicle