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Monoclonal Antibodies
Lufepirsen Eye Gel for Corneal Ulcer (NEXPEDE-1 Trial)
Phase 2 & 3
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
Awards & highlights
NEXPEDE-1 Trial Summary
This trial is testing the safety and effectiveness of a new eye gel to treat persistent corneal epithelial defects.
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.Check my eligibility
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.See study design
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.
NEXPEDE-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 1, 2, 3, 4, 5, 6, 7, 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1, 2, 3, 4, 5, 6, 7, 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Achieve Corneal Re-epithelialization Including Durability (CRC)
Secondary outcome measures
Achieve Corneal Re-epithelialization (CRC)
Achieve Corneal Re-epithelialization (Investigator)
Achieve Corneal Re-epithelialization Including Durability (Investigator)
+10 moreNEXPEDE-1 Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: NEXAGON® (lufepirsen ophthalmic gel) Low Dose ConcentrationExperimental Treatment1 Intervention
Lufepirsen (Low dose concentration) applied topically weekly for 4 to 8 weeks.
Group II: NEXAGON® (lufepirsen ophthalmic gel) High Dose ConcentrationExperimental Treatment1 Intervention
Lufepirsen (High dose concentration) applied topically weekly for 4 to 8 weeks.
Group III: NEXAGON Vehicle (ophthalmic gel)Placebo Group1 Intervention
Vehicle applied topically weekly for 4 to 8 weeks.
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Who is running the clinical trial?
Amber Ophthalmics, Inc.Lead Sponsor
1 Previous Clinical Trials
108 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an eyelid or tear gland condition that needs treatment.I am not taking any medications that are not allowed in the study.My condition has lasted 2 weeks and hasn't improved with standard treatments.My condition hasn't improved in 2 weeks despite standard treatments.I am either postmenopausal, surgically sterilized, or not pregnant.I have had a cornea transplant or multiple specific cornea surgeries.I had eye surgery or procedures without completing the required recovery time.I am using eye drops for another eye condition.I have not used Oxervate in the last 30 days.I have an ongoing eye infection causing a corneal defect.I have an active eye infection needing treatment.I have a severe ulcer or hole in the cornea of my eye.
Research Study Groups:
This trial has the following groups:- Group 1: NEXAGON® (lufepirsen ophthalmic gel) High Dose Concentration
- Group 2: NEXAGON® (lufepirsen ophthalmic gel) Low Dose Concentration
- Group 3: NEXAGON Vehicle (ophthalmic gel)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there a number of locales in this city running the clinical experiment?
"At present, the experiment is running in 6 sites scattered throughout Torrance, Grand Junction and Atlanta, among other cities. If you choose to join this trial, we suggest that you select the closest centre to curtail travel costs."
Answered by AI
Are there currently any opportunities to enroll in this clinical investigation?
"As per the clinicaltrials.gov records, this trial is currently enrolling participants. It was initially announced on July 1st 2023 and was updated as recently as July 21st of the same year."
Answered by AI
How extensive is the recruitment for this clinical experiment?
"Correct. Clinicaltrials.gov lists this medical experiment, which was originally announced on July 1st 2023, as presently recruiting individuals to participate in the trial. Approximately 120 participants have to be registered between 6 distinct sites."
Answered by AI
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