Efficacy and Safety Evaluation of SMO1 in Patients With Retinal Vein Occlusive Macular Edema

Официальное название

A Multicenter, Randomized, Double-blind, Parallel Design, Active-controlled Phase 3 Study to Determine Efficacy and Safety Following Administration of SMO1 in Patients With Retinal Vein Occlusive Macular Edema

Обзор

This is a multicenter, randomized, double-masked, parallel-group, active-controlled Phase 3 clinical trial designed to evaluate the efficacy and safety of SMO1 (Dexamethasone 700μg intravitreal implant) compared with the reference drug (Dexamethasone 700μg intravitreal implant) in patients with retinal vein occlusion (RVO)-associated macular edema. Participants are randomized in a 1:1 ratio to receive either the reference drug or the investigational product, SMO1, following screening and baseline assesments. Randomization is centrally managed and stratified by RVO subtype (branch or central). Patients are followed for 6 months with scheduled visits to assess efficacy and safety endpoints. A total of 312 participants (156 per treatment arm) will be enrolled.

Вмешательства

• Препарат Reference Drug
  1. Pre-treatment: Ofloxacin Eye Drop TID for 3 days before and after the administration of the reference drug (Day -3 \~ 3). 2. Single administration of the reference drug at Day 0.
• Препарат SMO1
  1\. Pre-treatment: Ofloxacin Eye Drop TID for 3 days before and after the administration of the reference drug (Day -3 \~ 3). 2. Single administration of SMO1 at Day 0.

Первичные конечные точки

• Best corrected visual acuity (BCVA) at Month 2 [Срок оценки: Month 2]

Вторичные конечные точки (3)

• BCVA at Month 1, 3, and 6 [Срок оценки: Month 1, 3, and 6]
• BCVA improvement of 15 letters (3 lines) or more [Срок оценки: Month 1, 2, 3, and 6]
• Central retinal thickness (CRT) at each visit [Срок оценки: Month 1, 2, 3, and 6]

Критерии участия

Критерии включения

• 19 years of age or older
• A study eye diagnosed with macular edema following i) branch retinal vein occlusion (BRVO) within 12 months prior to the screening visit or; ii) central retinal vein occlusion (CRVO) within 9 months prior to the screening visit
• A study eye with CRT measured to be 300μm or greater using OCT at the screening visit
• A study eye with BCVA between 34 and 68 letters at the screening visit and the baseline (comparable to Snellen score between 20/200 and 20/50)
• Provided written informed consent voluntarily after receiving a full explanation of the clinical trial

Критерии исключения

• A study eye with visual improvement determined to be highly unlikely due to the baseline condition of the eye
• A study eye with macular edema caused by the formation of an epiretinal membrane or visual improvement determined to be highly unlikely even if the macular edema decreases
• A study eye with uncontrolled glaucoma with intraocular pressure of 25mmHg or higher despite medical treatment at the screening visit
• A study eye with severe media opacity such as corneal opacity, cataracts, or vitreous hemorrhage

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

South Korea · 1 центр

• Kyung Hee University Hospital at Gangdong — Seoul

Идентификаторы

NCT: NCT07708142 · SMO1-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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