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Набор скоро начнётся NCT07743489

RB-PDT for Fusarium Keratitis: The LUMIERE Study

Фаза III С лечением Fusarium Keratitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Rose Bengal Photodynamic Therapy, Sham RB-PDT.
Кому может быть актуально
Состояния в реестре: Fusarium Keratitis. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США, Бразилия, Индия
Следующий шаг
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Официальное название

Light for Ulcer Management by Infection Elimination and Resistance Enhancement (LUMIERE)

Обзор

This is a multicenter trial with recruitment planned at ophthalmology clinics specializing in corneal diseases in India, Brazil, and at Stanford University and Bascom Palmer Eye Institute in the United States. Fusarium keratitis is common in tropical and subtropical regions like Florida, India and Brazil, which will facilitate access to the required number of participants. The study aims to recruit a total of 434 participants (217 per group).

Подробное описание

Participants with fusarium corneal ulcers will be randomized in a 1:1 fashion to one of two arms:

* Group 1, RB-PDT: natamycin 5%/Amphotericin B 0.15% plus RB-PDT * Group 2, Sham RB-PDT: natamycin 5%/Amphotericin B 0.15% plus sham RB-PDT

Participants will begin topical antimicrobial upon initial diagnosis: applied to the affected eye every hour while awake for the first week, then every 2 hours while awake for 3 weeks. Thereafter, application will be tapered at the discretion of the treating physician based on response to therapy.

RB-PDT/sham RB-PDT will occur within 5 days of initial smear/culture. For Group 1, Rose Bengal (0.1% RB in 0.9% sodium chloride) will be applied in 3-minute intervals to the de-epithelialized cornea for 30 minutes followed by irradiation with a 6mW/cm2 custom-made green LED source for 15 minutes (5.4J/cm2). Participants in Group 2 will undergo a sham procedure using topical balanced salt solution and pen light covered with a green filter. Study participants will undergo repeat scraping and culture of the corneal ulcer 30 minutes after the assigned RB-PDT procedure.

A second RB-PDT/sham RB-PDT procedure and repeat smear/culture will occur one week after the first procedure, following the same protocol.

Вмешательства

  • Препарат Rose Bengal Photodynamic Therapy
    RB-PDT/sham RB-PDT will occur within 5 days of initial smear/culture. For Group 1, Rose Bengal (0.1% RB in 0.9% sodium chloride) will be applied in 3-minute intervals to the de-epithelialized cornea for 30 minutes followed by irradiation with a 6mW/cm2 custom-made green LED source for 15 minutes (5.4J/cm2). A second RB-PDT procedure and repeat smear/culture will occur one week after the first procedure, following the same protocol.
  • Препарат Sham RB-PDT
    Participants in Group 2 will undergo a sham procedure using topical balanced salt solution and pen light covered with a green filter. Study participants will undergo repeat scraping and culture of the corneal ulcer 30 minutes after the assigned RB-PDT procedure. A second sham RB-PDT procedure and repeat smear/culture will occur one week after the first procedure, following the same protocol.

Первичные конечные точки

  • BSCVA at 3 months [Срок оценки: 3 months post-op]

Критерии участия

Критерии включения

  • Presence of culture positive fusarium fungal keratitis
  • Age over 18 years
  • Moderate to severe vision loss, defined as Snellen visual acuity of 20/40 (6/12) to 20/400 (6/120)
  • Corneal thickness ≥350 µm, as measured on AS-OCT
  • Basic understanding of the study as determined by the physician
  • Commitment to return for follow up visits

Критерии исключения

  • History of hypersensitivity to Rose Bengal
  • Evidence of concomitant infection on exam, gram stain, or confocal microscopy (i.e. herpes, both bacteria and acanthamoeba on gram stain)
  • History of intraocular surgery within the last three months\*
  • Impending or frank perforation at recruitment
  • Involvement of sclera at presentation
  • Presence of desmetocele at recruitment
  • Non-infectious or autoimmune keratitis
  • History of corneal transplantation
  • Pinhole visual acuity worse than 20/200 in the unaffected eye
  • Participants who are decisionally and/or cognitively impaired

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
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Stanford University — Palo Alto
  • University of Miami - Bascom Palmer Eye Institute — Miami
Бразилия · 1 центр
  • Federal University of São Paulo — São Paulo
Индия · 1 центр
  • Aravind Eye Care System — Madurai

Идентификаторы

NCT: NCT07743489 · 86425

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗