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

Phase 2

Terminated

• Conditions: Corneal Persistent Epithelial Defect
• Interventions: Drug: Nexagon® (lufepirsen) High Dose Concentration; Drug: Nexagon® (lufepirsen) Low Dose Concentration; Drug: Vehicle; Drug: Open-label Nexagon® (lufepirsen)

• Registration Number: NCT04081103
• Lead Sponsor: Amber Ophthalmics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-09
• Study Start: 2020-06-30
• Primary Completion: 2022-02-07
• Study Completion: 2022-02-07
• Results First Submitted: 2024-08-13
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-21
• Last Update Submitted: 2024-10-21
• Results First Posted: 2024-10-23
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nexagon® (lufepirsen) High Dose Concentration	Nexagon® (lufepirsen) High Dose Concentration	-
Nexagon® (lufepirsen) High Dose Concentration	Open-label Nexagon® (lufepirsen)	-
Nexagon® (lufepirsen) Low Dose Concentration	Nexagon® (lufepirsen) Low Dose Concentration	-
Nexagon® (lufepirsen) Low Dose Concentration	Open-label Nexagon® (lufepirsen)	-
Vehicle	Vehicle	-
Vehicle	Open-label Nexagon® (lufepirsen)	-

Primary Outcome Measures

Name	Time	Method
The Proportion of Subjects Achieving Corneal Epithelial Recovery, as Assessed by Slit Lamp Examination.	Up to 56 days.	Corneal epithelial recovery, defined as corneal reepithelialization and maintenance of a durable epithelium for at least 28 days, will be assessed by slit lamp examination.
Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v 5.0	Up to 30 days after last application of intervention	Incidence of Treatment Emergent Adverse Events as assessed by CTCAE v 5.0.

Trial Locations

Locations (1)

Jules Stein Eye Institute; 🇺🇸 Los Angeles, California, United States