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Monoclonal Antibodies

Lufepirsen Eye Gel for Corneal Ulcer (NEXPEDE-1 Trial)

Phase 2
Recruiting
Research Sponsored by Amber Ophthalmics, 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 weeks 1, 2, 3, 4, 5, 6, 7, 8

Summary

This trial is testing NEXAGON, an eye gel, on patients with persistent eye surface wounds that don't heal with usual treatments. The gel helps the eye's surface cells grow back and heal the wound.

Who is the study for?
This trial is for individuals with persistent corneal epithelial defects (PCED) lasting at least 2 weeks and unresponsive to standard treatments. Participants must not show improvement in the last 2 weeks despite treatment, be capable of consent, and if childbearing potential, not pregnant or sterilized. Exclusions include recent ocular surgery without proper washout time, other eye diseases requiring medication, active infections or history of certain keratoplasty procedures.
What is being tested?
The study tests NEXAGON® (lufepirsen ophthalmic gel) against a placebo vehicle to assess its safety and effectiveness in treating PCED. Patients will be randomly assigned to receive either the experimental gel or a placebo while their health outcomes are monitored.
What are the potential side effects?
While specific side effects for NEXAGON® are not listed here, common side effects from ophthalmic gels may include eye irritation, discomfort upon application, redness, itching or swelling around the eyes. Hypersensitivity reactions could also occur.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1, 2, 3, 4, 5, 6, 7, 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 2, 3, 4, 5, 6, 7, 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Achieve Corneal Re-epithelialization Including Durability (CRC)
Secondary study objectives
Achieve Corneal Re-epithelialization (CRC)
Achieve Corneal Re-epithelialization (Investigator)
Achieve Corneal Re-epithelialization Including Durability (Investigator)
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NEXAGON® (lufepirsen ophthalmic gel) High Dose ConcentrationExperimental Treatment1 Intervention
Lufepirsen (High dose concentration) applied topically weekly for 4 to 8 weeks.
Group II: NEXAGON Vehicle (ophthalmic gel)Placebo Group1 Intervention
Vehicle applied topically weekly for 4 to 8 weeks.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for corneal ulcers include antibiotics, antifungals, antivirals, and anti-inflammatory agents. Antibiotics and antifungals work by eliminating bacterial and fungal pathogens, respectively, which are common causes of corneal ulcers. Antivirals target viral infections that can lead to ulceration. Anti-inflammatory agents reduce inflammation and pain, promoting a more conducive environment for healing. NEXAGON® (lufepirsen ophthalmic gel) specifically targets connexin43, a protein involved in cell communication and wound healing, to promote corneal healing. This is particularly important for corneal ulcer patients as it directly addresses the healing process, potentially reducing recovery time and improving outcomes.
Neprilysin inhibition promotes corneal wound healing.Re-epithelialization of the rabbit cornea is regulated by opioid growth factor.

Find a Location

Who is running the clinical trial?

Amber Ophthalmics, Inc.Lead Sponsor
1 Previous Clinical Trials
35 Total Patients Enrolled

Media Library

NEXAGON® (Lufepirsen Ophthalmic Gel) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05966493 — Phase 2
Corneal Ulcer Research Study Groups: NEXAGON® (lufepirsen ophthalmic gel) High Dose Concentration, NEXAGON Vehicle (ophthalmic gel)
Corneal Ulcer Clinical Trial 2023: NEXAGON® (Lufepirsen Ophthalmic Gel) Highlights & Side Effects. Trial Name: NCT05966493 — Phase 2
NEXAGON® (Lufepirsen Ophthalmic Gel) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05966493 — Phase 2
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