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Trial record 1 of 1 for:    A Randomized, Multicenter, Double-Masked, Vehicle -Controlled Phase 2/3 Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects with Persistent Corneal Epithelial Defects (NEXPEDE-1)
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A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED (NEXPEDE-1)

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ClinicalTrials.gov Identifier: NCT05966493
Recruitment Status : Recruiting
First Posted : July 28, 2023
Last Update Posted : July 28, 2023
Sponsor:
Information provided by (Responsible Party):
Amber Ophthalmics, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Persistent Corneal Epithelial Defect Drug: lufepirsen Drug: Vehicle Phase 2 Phase 3

Detailed Description:
This study is a randomized, multicenter, double-masked, vehicle-controlled study to evaluate the safety and efficacy of NEXAGON (lufepirsen ophthalmic gel) in subjects with persistent corneal epithelial defects (PCED). The study will enroll subjects who will complete a Screening Period, Treatment Period (up to 8 weeks) and Follow-up Period (4 weeks). Those subjects whose defect has not re-epithelialized by the completion of the Treatment Period or who achieved re-epithelialization but failed to maintain re-epithelialization for 28 days after treatment completion (durability) are eligible to enter the NEXAGON Open-label Treatment Period for an additional 8 weeks.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Phase 2/3 Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With Persistent Corneal Epithelial Defects (NEXPEDE-1)
Estimated Study Start Date : July 2023
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: NEXAGON® (lufepirsen ophthalmic gel) High Dose Concentration
Lufepirsen (High dose concentration) applied topically weekly for 4 to 8 weeks.
 Drug: lufepirsen
Lufepirsen is an unmodified connexin43 antisense oligonucleotide.
Other Name: NEXAGON®
Experimental: NEXAGON® (lufepirsen ophthalmic gel) Low Dose Concentration
Lufepirsen (Low dose concentration) applied topically weekly for 4 to 8 weeks.
 Drug: lufepirsen
Lufepirsen is an unmodified connexin43 antisense oligonucleotide.
Other Name: NEXAGON®
Placebo Comparator: NEXAGON Vehicle (ophthalmic gel)
Vehicle applied topically weekly for 4 to 8 weeks.
 Drug: Vehicle
Matching vehicle without lufepirsen.
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Achieve Corneal Re-epithelialization Including Durability (CRC) [ Time Frame: End of Study: 28 Days after achieving re-epithelialization ]
    The proportion of subjects achieving corneal re-epithelialization that is maintained for a minimum of 28 days, based on assessment of corneal fluorescein staining images of the PCED by a Central Reading Center (CRC).


Secondary Outcome Measures :
  1. Achieve Corneal Re-epithelialization Including Durability (Investigator) [ Time Frame: End of Study: 28 Days after achieving re-epithelialization ]
    The proportion of subjects achieving corneal re-epithelialization that is maintained for a minimum of 28 days, based on assessment of corneal fluorescein staining of the PCED by the Investigator

  2. Achieve Corneal Re-epithelialization (CRC) [ Time Frame: Weeks 1, 2, 3, 4, 5, 6, 7, 8 ]
    The proportion of subjects achieving corneal re-epithelialization, based on assessment of corneal fluorescein staining images of the PCED by a CRC.

  3. Achieve Corneal Re-epithelialization (Investigator) [ Time Frame: Weeks 1, 2, 3, 4, 5, 6, 7, 8 ]
    The proportion of subjects achieving corneal re-epithelialization based on assessment of corneal fluorescein staining images of the PCED by Investigator.

  4. Number of Dose Administrations Required to Achieve Corneal Re-epithelialization (CRC) [ Time Frame: Weeks 1, 2, 3, 4, 5, 6, 7, 8 ]
    The number of dose administrations subjects required to achieve corneal re-epithelialization that is maintained for a minimum of 28 days after completing treatment, based on assessment of corneal fluorescein staining images of the PCED by a CRC.

  5. Number of Dose Administrations Required to Achieve Corneal Re-epithelialization (Investigator) [ Time Frame: Weeks 4, 5, 6, 7, 8 ]
    The number of dose administrations subjects required to achieve corneal re-epithelialization that is maintained for a minimum of 28 days after completing treatment, based on assessment of corneal fluorescein staining images of the PCED by Investigator.

  6. Time to Corneal Re-epithelialization (CRC) [ Time Frame: Weeks 1, 2, 3, 4, 5, 6, 7, 8 ]
    The time (in days) to corneal re-epithelialization, defined as the time from randomization to the time of corneal re-epithelialization based on assessment of corneal fluorescein staining images of the PCED by a CRC.

  7. Time to Corneal Re-epithelialization (Investigator) [ Time Frame: Weeks 1, 2, 3, 4, 5, 6, 7, 8 ]
    The time (in days) to corneal re-epithelialization, defined as the time from randomization to the time of corneal re-epithelialization based on assessment of corneal fluorescein staining images of the PCED by Investigator.

  8. Ocular Pain Assessment Survey [ Time Frame: End of Study: Week 9, 10, 11, or 12 ]
    The mean change from baseline (CFB) in ocular pain based on Ocular Pain Assessment Survey (OPAS).

  9. Assessment of visual health status indices by the administration of the NEI Visual Function Questionnaire (NEI-VFQ-25). [ Time Frame: End of Study: Week 9, 10, 11, or 12 ]
    Assess the change from baseline in the subject's visual health status using the NEI-VFQ-25 (0-100, higher scores representing a better status).

  10. Visual Acuity Assessment [ Time Frame: End of Study: Week 9, 10, 11, or 12 ]
    The mean CFB in Best Corrected Distance Visual Acuity (BCDVA).

  11. Visual Acuity Improvement [ Time Frame: End of Study: Week 9, 10, 11, or 12 ]
    The proportion of subjects who achieve a 15 letter (ETDRS) gain in BCDVA.

  12. Open-label Treatment Period [ Time Frame: Open-label Day 1 ]
    The proportion of subjects requiring open-label treatment during the Treatment Period.

  13. Achieve Corneal Re-epithelialization in Open-label Treatment Period [ Time Frame: End of Study: 28 Days after achieving re-epithelialization ]
    The proportion of subjects in the Open-Label Treatment Period that achieve re-epithelialization of the corneal epithelial defect that remains durable for a minimum of 28 days based on the CRC assessment on images.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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. PCED measures at least 2 mm along the largest diameter
  4. Subject must provide written informed consent (or assent)
  5. Subjects with childbearing potential must be 1-year postmenopausal, surgically sterilized, or have a negative urine pregnancy test

Exclusion Criteria:

  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 in the opinion of the Investigator is deemed to be clinically relevant and/or active
  5. Have a history of a full thickness keratoplasty, > 1 Descemet membrane endothelial keratoplasty (DMEK) or Descemet's stripping endothelial keratoplasty (DSEK) procedure
  6. Have a history of ocular surgery or any ocular procedure(s) not meeting the designated washout time
  7. Have any other ocular disease requiring topical ocular medication in the affected eye
  8. A Schirmer I test result (without anesthesia) of ≤ 3 mm/5 minutes in the study eye
  9. Have a presence or history of any ocular or systemic disorder or condition that, in the judgement of the Investigator, might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be incompatible with the study visit schedule or conduct
  10. Have a known hypersensitivity to one of the components of the study or procedural medications (e.g., NEXAGON, fluorescein)
  11. Participated in an interventional clinical drug or device trial within 28 days prior to Day 1
  12. Use of the medications presented in the protocol that are prohibited in the study.
  13. Use of Oxervate within 30 days of study enrollment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05966493


Contacts
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Contact: President and CSO, PharmD 858-663-1500 clinical@amberophthalmics.com

Locations
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United States, California
Principal Investigator Recruiting
Pasadena, California, United States, 91107
Contact: Study Coordinator    626-793-3625 ext 0      
Principal Investigator Recruiting
Torrance, California, United States, 90505
Contact: Study Coordinator    310-602-5640    tstudy1@wgea.com   
United States, Colorado
Principal Investigator Recruiting
Grand Junction, Colorado, United States, 81501
Contact: Study Coordinator    970-205-9555    Chris.Bosch@iconeyecare.com   
United States, Georgia
Principal Investigator Recruiting
Atlanta, Georgia, United States, 30339
Contact: Study Coordinator    404-351-2220      
United States, Tennessee
Principal Investigator Recruiting
Nashville, Tennessee, United States, 37215
Contact: Study Coordinator    615-327-4015      
United States, Texas
Principal Investigator Recruiting
San Antonio, Texas, United States, 78238
Contact: Study Coordinator    210-226-6169      
Sponsors and Collaborators
Amber Ophthalmics, Inc.
More Information
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Responsible Party: Amber Ophthalmics, Inc.
ClinicalTrials.gov Identifier: NCT05966493    
Other Study ID Numbers: AMB-01-006
First Posted: July 28, 2023    Key Record Dates
Last Update Posted: July 28, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amber Ophthalmics, Inc.:
PCED
Corneal Defect
PED