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

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат lufepirsen high dose
  Lufepirsen is an unmodified connexin43 antisense oligonucleotide.
• Препарат Vehicle
  Matching vehicle without lufepirsen.
• Препарат lufepirsen low dose
  Lufepirsen is an unmodified connexin43 antisense oligonucleotide.

Первичные конечные точки

• Achieve Corneal Re-epithelialization Including Durability (CRC) [Срок оценки: End of Study: 28 Days after achieving re-epithelialization]

Критерии участия

Критерии включения

• 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
• Have no clinical evidence of improvement in the PCED within 2 weeks prior to randomization despite the use of non-surgical SOC treatment
• Subject must provide written informed consent (or assent)
• Subjects with childbearing potential must be 1-year postmenopausal, surgically sterilized, or have a negative urine pregnancy test

Критерии исключения

• Have a known ocular infection that is deemed to be active requiring therapeutic intervention
• 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
• Present with evidence of corneal ulceration/melting involving the posterior third of the stroma and/or perforation in either eye
• Have a blepharitis or meibomian gland disease in the study eye that is deemed to be clinically relevant and/or active
• Have a history of ocular surgery or any ocular procedure(s) not meeting the designated washout time
• Have any other ocular disease requiring topical ocular medication in the affected eye
• 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
• Have a known hypersensitivity to one of the components of the study or procedural medications (e.g., NEXAGON, fluorescein)
• Participated in an interventional clinical drug or device trial within 28 days prior to Day 1
• Use of the medications presented in the protocol that are prohibited in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 21 центр

• Glaukos Investigative Site — Dothan
• Glaukos Investigative Site — Petaluma
• Glaukos Investigative Site — Torrance
• Glaukos Investigative Site — Colorado Springs
• Glaukos Investigative Site — Grand Junction
• Glaukos Investigative Site — Bradenton
• Glaukos Investigative Site — Fort Myers
• Glaukos Investigative Site — South Miami
• … и ещё 13 центров

Испания · 4 центра

• Glaukos Investigative Site — Barcelona
• Glaukos Investigative Site — Madrid
• Glaukos Investigative Site — Seville
• Glaukos Investigative Site — Zaragoza

Германия · 2 центра

• Glaukos Investigative Site — Mainz
• Glaukos Investigative Site — München

Италия · 1 центр

• Glaukos investigative Site — Messina

Идентификаторы

NCT: NCT05966493 · GLK-601-01 (AMB-01-006)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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