Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration

Официальное название

Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration (i-SIGHT2): a Multicentre, Randomised, Sham-controlled, Double-masked, Clinical Device Trial.

Обзор

The goal of this clinical trial is to characterize the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in patients with intermediate to advanced nonexudative AMD. Participants will: * Undergo an initial loading regimen, followed by 7 maintenance over the course of 11 months. * Participants will return monthly through Month 14 (3 months post-last treatment) for evaluation and monitoring.

Вмешательства

• Устройство i-Lumen AMD
  i-Lumen AMD transpalpebral microcurrent stimulation system

Первичные конечные точки

• Mean Change BCVA from Baseline [Срок оценки: Month 3]

Вторичные конечные точки (2)

• Portion of per-eye Responders [Срок оценки: Month 3]
• Mean Change BCVA from Baseline [Срок оценки: Month 6]

Критерии участия

Критерии включения

• Presence of at least one large druse >125 microns in diameter due to AMD.
• BCVA letter score of 35 to 70 letters (inclusive) (Snellen equivalent 6/12 to 6/60 \[20/40 to 20/200\])

Критерии исключения

• Any implanted electrical device(s) including deep brain stimulator, hearing or visual implants (i.e., cochlear implant, auditory brainstem implant, retinal prostheses), and/or cardiac defibrillator/pacemaker.
• Implanted metallic device within 20 cm of the Treatment electrode (study eye(s)) and/or the grounding electrode (base of the hairline on the back of the neck).
• Uncontrolled diabetes, defined as glycated haemoglobin (HbA1c) >10% (13.3 mmol/L).
• Current tobacco or tobacco-related product use or history within the past 5 years of heavy smoking (defined as, on average, more than half a pack of cigarettes per day).
• Known severe allergy to fluorescein dye.
• Medical diagnosis of severe dry eye defined as requiring either artificial tears more than six (6) times a day or prescription drops (i.e., Restasis, Xiidra, or Cequa).
• History of seizure disorders, chronic migraines and/or cluster headaches.
• History and/or evidence of diabetic retinopathy in either eye as assessed by CF, fundus fluorescein angiography (FA), and OCT, to be confirmed by the Central Reading Centre.
• Other conditions which pre-dispose to chorioretinal atrophy such as inherited retinal dystrophy (i.e., Stargardt's disease, Best's disease, pattern dystrophy, central areolar choroidal dystrophy, etc.).
• History and/or evidence of exudative AMD in the study eye as assessed by CF, FA (or OCT-A ), and OCT, to be confirmed by Central Reading Centre.
• GA involving the foveal centre, as assessed by the Central Reading Centre using AF and OCT.
• History of intravitreal injections for GA (e.g., Syfovre or Izervay).
• Treatment with photobiomodulation (PBM) therapy or short pulse laser within 12 months prior to screening.
• Glaucoma requiring ≥3 medications and/or drops per day, or history of trabeculectomy.
• History of any kind of intraocular surgery, excluding cataract surgery performed ≥3 months from Screening.
• History of yttrium aluminium garnet (YAG) laser posterior capsulotomy <1 month from Screening.
• Visually significant cataracts and/or visually significant posterior capsular opacification.
• History of amblyopia.

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 · 5 центров

• Retina Consultants PC — Manchester
• University Retina & Macula Associates — Lemont
• Sierra Eye Associates — Reno
• Texas Retina Associates — Fort Worth
• Tyler Retina Research Insitute — Tyler

Австралия · 4 центра

• Sydney Eye Hospital — Sydney
• Hobart Eye Surgeons — Hobart
• Adelaide Eye & Retina Centre — Adelaide
• Cerulea — East Melbourne

Великобритания · 4 центра

• Queens University Belfast / Belfast City Hospital — Belfast
• King's College Hospital — London
• London North West University Healthcare — Middlesex
• Sunderland Eye Infirmary — Sunderland

Новая Зеландия · 2 центра

• Auckland Eye Limited — Remuera
• Southern Eye Specialist — Christchurch

Идентификаторы

NCT: NCT06662162 · ILS-AMD-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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