Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

Официальное название

Randomized, Multicenter, Vehicle-Controlled, Double-Masked Phase 3 Study to Evaluate the Efficacy and Safety of Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF]) in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

Обзор

This is a phase 3, randomized, multicenter, vehicle-controlled, double-masked study to evaluate the efficacy and safety of intranasal cenegermin compared with vehicle control in adult participants with NAION. Approximately 272 participants who meet all eligibility criteria will be randomly assigned in a 1:1 ratio to receive either cenegermin treatment (Group 1) or the vehicle control (Group 2).

Вмешательства

• Препарат Cenegermin
  Cenegermin is administered intranasally.
• Другое Vehicle
  Vehicle spray is administered intranasally.

Первичные конечные точки

• Achievement of ≥ 15 letter increase in Best Corrected Visual Acuity (BCVA), assessed in each individual participant, measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart [Срок оценки: Baseline to Week 24]

Вторичные конечные точки (5)

• Change from baseline in visual field mean sensitivity in decibels [Срок оценки: Baseline through Week 24]
• Change from baseline in BCVA as measured by the ETDRS chart [Срок оценки: Baseline through Week 24]
• Change from baseline in visual field mean sensitivity, in a prespecified region consisting of at least 5 separate loci on visual field testing [Срок оценки: Baseline through Week 24]
• Change from baseline in ganglion cell layer-inner plexiform layer (GCL-IPL) thickness (micrometer [μm]) on optical coherence tomography (OCT). [Срок оценки: Baseline through Week 24]
• Incidence of ocular and non-ocular adverse events [Срок оценки: Through Week 24]

Критерии участия

Критерии включения

• A clinical diagnosis of unilateral NAION in the study eye with symptom onset within 14 days prior to the planned date for first dose administration.
• A BCVA score in the study eye of ≥ 15 letters and ≤ 65 letters measured using the ETDRS chart.
• Sufficiently clear ocular media and adequate pupil dilation to enable assessment of the optic nerve and retina in both eyes.

Критерии исключения

• Bilateral NAION or sequential NAION with fellow eye involvement within 6 weeks of study eye involvement.
• Clinical evidence of temporal arteritis (giant cell arteritis) signs or symptoms.
• Abnormal laboratory findings suggestive of temporal arteritis (giant cell arteritis), in the absence of a known acute cause
• Pain with eye movement
• Intraocular pressure (IOP) greater than 25 mmHg in the study eye or history of glaucoma in the study eye.
• Intermediate age-related macular degeneration (AMD) with subfoveal drusen, exudative AMD, or geographic atrophy in the study eye.

Note: Additional inclusion/exclusion criteria apply, as defined in the protocol.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 18 центров

• Neuro Eye Orbit Institute — Los Angeles
• David Geffen School of Medicine at UCLA - Ophthalmology — Los Angeles
• California Orbital Consultants — Newport Beach
• University of Colorado Anschutz Medical Campus — Aurora
• Bascom Palmer Eye Institute, University of Miami School of Medicine — Miami
• Sarasota Retina Institute - Research — Sarasota
• Northwestern University - Ophthalmology — Chicago
• University of Illinois at Chicago Eye and Ear Infirmary - Ophthalmology — Chicago
• … и ещё 10 центров

Идентификаторы

NCT: NCT07453888 · NGF-NAION-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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