RECRUITING

A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED

Conditions

Persistent Corneal Epithelial Defect PCED Corneal Defect PED

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is to evaluate the safety and efficacy of NEXAGON® (lufepirsen ophthalmic gel) (NEXAGON) in subjects with persistent corneal epithelial defects (PCED). The objectives of the study are to evaluate the safety and efficacy of NEXAGON in this population.

Official Title

A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With Persistent Corneal Epithelial Defects (NEXPEDE-1)

Quick Facts

Study Start:2023-08-17

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05966493

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Have a PCED that is at least 2 weeks in duration and refractory to one or more conventional non-surgical standard of care (SOC) treatments 2. Have no clinical evidence of improvement in the PCED within 2 weeks prior to randomization despite the use of non-surgical SOC treatment 3. Subject must provide written informed consent (or assent) 4. Subjects with childbearing potential must be 1-year postmenopausal, surgically sterilized, or have a negative urine pregnancy test	1. Have a known ocular infection that is deemed to be active requiring therapeutic intervention 2. Present with a corneal surface defect in either eye that is directly attributed to an infectious etiology (bacterial, viral, fungal and/or protozoal) that has not fully resolved and/or treatment has not been completed 3. Present with evidence of corneal ulceration/melting involving the posterior third of the stroma and/or perforation in either eye 4. Have a blepharitis or meibomian gland disease in the study eye that is deemed to be clinically relevant and/or active 5. Have a history of ocular surgery or any ocular procedure(s) not meeting the designated washout time 6. Have any other ocular disease requiring topical ocular medication in the affected eye 7. Have a presence or history of any ocular or systemic disorder or condition that could interfere the safety or efficacy of the study treatment, or the interpretation of the study results 8. Have a known hypersensitivity to one of the components of the study or procedural medications (e.g., NEXAGON, fluorescein) 9. Participated in an interventional clinical drug or device trial within 28 days prior to Day 1 10. Use of the medications presented in the protocol that are prohibited in the study.

Inclusion Criteria

Exclusion Criteria

1. Have a PCED that is at least 2 weeks in duration and refractory to one or more conventional non-surgical standard of care (SOC) treatments
2. Have no clinical evidence of improvement in the PCED within 2 weeks prior to randomization despite the use of non-surgical SOC treatment
3. Subject must provide written informed consent (or assent)
4. Subjects with childbearing potential must be 1-year postmenopausal, surgically sterilized, or have a negative urine pregnancy test

1. Have a known ocular infection that is deemed to be active requiring therapeutic intervention
2. Present with a corneal surface defect in either eye that is directly attributed to an infectious etiology (bacterial, viral, fungal and/or protozoal) that has not fully resolved and/or treatment has not been completed
3. Present with evidence of corneal ulceration/melting involving the posterior third of the stroma and/or perforation in either eye
4. Have a blepharitis or meibomian gland disease in the study eye that is deemed to be clinically relevant and/or active
5. Have a history of ocular surgery or any ocular procedure(s) not meeting the designated washout time
6. Have any other ocular disease requiring topical ocular medication in the affected eye
7. Have a presence or history of any ocular or systemic disorder or condition that could interfere the safety or efficacy of the study treatment, or the interpretation of the study results
8. Have a known hypersensitivity to one of the components of the study or procedural medications (e.g., NEXAGON, fluorescein)
9. Participated in an interventional clinical drug or device trial within 28 days prior to Day 1
10. Use of the medications presented in the protocol that are prohibited in the study.

Contacts and Locations

Study Contact

Study Manager

CONTACT

858-539-3418

clinical@AmberOphthalmics.com

Study Locations (Sites)

Principal Investigator

Newport Beach, California, 92663

United States

Collaborators and Investigators

Sponsor: Amber Ophthalmics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-17

Study Completion Date2025-12

Study Record Updates

Study Start Date2023-08-17

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

PCED
Corneal Defect
PED

Additional Relevant MeSH Terms

Persistent Corneal Epithelial Defect