- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04081103
NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Chemical and/or Thermal Injuries (EXPEDE)
August 25, 2022 updated by: Amber Ophthalmics, Inc.
A Phase 2, Randomized, Prospective, Double-masked, Vehicle-controlled Study to Assess the Efficacy and Safety of Nexagon® (NEXAGON) Applied Topically in Subjects With Corneal Persistent Epithelial Defects Resulting From Severe Ocular Chemical and/or Thermal Injuries
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
108
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: President and CSO, PharmD
- Phone Number: (858) 663-1500
- Email: clinical@amberophthalmics.com
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Recruiting
- Jules Stein Eye Institute
-
Contact:
- Ellen Pascual
- Phone Number: 310-794-5592
- Email: pascual@jsei.ucla.edu
-
Principal Investigator:
- Anthony Aldave, MD
-
-
Colorado
-
Littleton, Colorado, United States, 80120
- Recruiting
- Colorado Eye Consultants
-
Contact:
- Shivam Patel
- Phone Number: 303-730-0404
- Email: spatel@corneaonline.com
-
Principal Investigator:
- S. Lance Forstot, MD
-
-
Kentucky
-
Edgewood, Kentucky, United States, 41017
- Recruiting
- Cincinnati Eye Institute
-
Contact:
- Katie Hogeback
- Phone Number: 4517 859-331-9000
- Email: khogeback@cvphealth.com
-
Principal Investigator:
- Edward Holland, MD
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Recruiting
- University of Minnesota
-
Contact:
- Joshua Hou, MD
- Phone Number: 612-626-1442
- Email: jhhou@umn.edu
-
Principal Investigator:
- Joshua Hou, MD
-
-
Missouri
-
Springfield, Missouri, United States, 65804
- Recruiting
- Mercy Eye Care
-
Contact:
- Diana Connelly
- Phone Number: 417-820-7493
- Email: diana.connelly@mercy.net
-
Principal Investigator:
- Zachary Seagrave, MD
-
-
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.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female of any age.
- 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.
- The PED is non-responsive to current standard of care for at least 14 days from injury.
- The PED measures at least 2 mm along the largest diameter at Day 1 of the Treatment Period.
- Providing written informed consent and ability to comply with the visit and dosing schedule.
Exclusion Criteria:
- Subjects who will be unlikely to tolerate the wearing of a Bandage Contact Lens.
- Have active ocular infection.
- Subjects with corneal perforation or impending corneal perforation.
- 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.
- Subjects receiving systemic corticosteroids (equivalent to GREATER THAN 10 mg/day of prednisone) or immunosuppressive or chemotherapeutic agents unless the dose has remained unchanged for 30 days and will remain unchanged during the study.
- Subjects being treated with systemic corticosteroids (equivalent to >10 mg/day of prednisone) or immunosuppressive or chemotherapeutic agents unless the dose has remained unchanged for 30 days prior to Day 1.
- Subjects with severe lid abnormalities or ocular conditions that contribute to the persistence of the epithelial defect.
- Female subjects of childbearing potential who are pregnant, nursing, planning a pregnancy or not using an adequate and medically acceptable form of birth control.
- Subjects who have participated in an interventional clinical trial within 30 days prior to Day 1.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Vehicle
|
Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase.
Vehicle is administered topically in the affected eye three (3) times over 28 days.
Other Names:
|
Experimental: Nexagon® (lufepirsen) High Dose Concentration
|
Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days.
Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase.
|
Experimental: Nexagon® (lufepirsen) Low Dose Concentration
|
Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase.
Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of subjects achieving corneal epithelial recovery, as assessed by slit lamp examination.
Time Frame: 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.
|
Up to 56 days.
|
Incidence of Treatment Emergent Adverse Events as assessed by CTCAE v 5.0
Time Frame: Up to 30 days after last application of intervention
|
Incidence of Treatment Emergent Adverse Events as assessed by CTCAE v 5.0.
|
Up to 30 days after last application of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to corneal epithelial recovery, as assessed by slit lamp examination.
Time Frame: Within 28 days
|
The time (number of days) from randomization to the time of initial re-epithelialization for a cornea that remains re-epithelialized and durable for at least 28 days will be recorded following confirmation by slit lamp examination.
|
Within 28 days
|
Improvement from baseline of visual acuity measured by the Snellen scale.
Time Frame: Up to 56 days
|
Improvement of visual acuity on the Snellen scale from baseline until study exit will be measured.
|
Up to 56 days
|
The number of NEXAGON treatment doses required to achieve recovery of the corneal epithelium will be assessed.
Time Frame: Within 56 days
|
The number of NEXAGON dose applications required to achieve corneal epithelial recovery will be recorded.
Corneal epithelial recovery is defined as corneal reepithelialization and maintenance of a durable epithelium for at least 28 days and will be confirmed by slit lamp examination.
|
Within 56 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start (Actual)
June 30, 2020
Primary Completion (Anticipated)
March 1, 2023
Study Completion (Anticipated)
March 1, 2023
Study Registration Dates
First Submitted
August 29, 2019
First Submitted That Met QC Criteria
September 4, 2019
First Posted (Actual)
September 9, 2019
Study Record Updates
Last Update Posted (Actual)
August 30, 2022
Last Update Submitted That Met QC Criteria
August 25, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- NEX-PED-005
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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