Effect of Omega-3 Fatty Acid Supplementation on Dry-AMD Progression

Официальное название

Effect of Krill Oil Supplementation on Dry Age-Related Macular Degeneration: A Randomized Controlled Trial

Обзор

This randomized, double-blind, placebo-controlled study aims to evaluate the effect of krill oil supplementation in patients with dry age-related macular degeneration (AMD). Participants will receive 4 capsules of krill oil or placebo daily for a period of 3 months. Outcomes will be evaluated after 3-month treatment to assess differences between the two study groups.

Вмешательства

• Пищевая добавка Krill Oil
  Qualified subjects start to take supplementation from Day 1 in the trial. Specifically, subjects from Intervention group take 4 capsules of krill oil per day.
• Пищевая добавка Olive Oil
  Qualified subjects start to take placebo from Day 1 in the trial. Specifically, subjects from placebo group take 4 capsules of olive oil, which has the same color and smell as the krill oil.

Первичные конечные точки

• Change in Macular Drusen Volume [Срок оценки: From enrollment to the end of follow-up at 3 months.]

Вторичные конечные точки (3)

• Change in Maximum Macular Drusen Height [Срок оценки: From enrollment to the end of follow-up at 3 months.]
• Change in Best-Corrected Visual Acuity [Срок оценки: From enrollment to the end of follow-up at 3 months.]
• Change in Self-Reported Visual Function [Срок оценки: From enrollment to the end of follow-up at 3 months.]

Критерии участия

Критерии включения

• Adults diagnosed with dry AMD at an early or intermediate stage, classified according to the Beckman Classification and confirmed by fundus photography: (1) Early AMD: medium drusen (>63 μm and ≤125 μm) without AMD-related pigmentary abnormalities; (2) Intermediate AMD: large drusen (>125 μm), with or without AMD-related pigmentary abnormalities.
• Willing to stop supplementation of omega-3 fatty acids, choline, or astaxanthin.
• Willing to sign the informed consent, and willing to attend follow-up visits for at least 3 months.

Критерии исключения

• Any eye with disease that would interfere with the fundus examinations.
• Eye with choroidal neovascularization (CNV), geographic atrophy (GA), or high myopia.
• Surgeries that may interfere with AMD evaluation.
• Long-term use of any medications that are associated with retinal or neural toxicities.
• History of supplementation with lutein, zeaxanthin, DHA, or EPA, unless a wash-out period of at least 8 weeks is completed prior to enrollment.
• Intraocular pressure more than 26 mmHg.
• Received cataract surgery in 3 months.
• Other conditions: subjects with severe systemic diseases; any condition that causes high risk of drop-out, or low compliance, for instance cognition disorder; have been involved in other trial that interfere with the current visit plan; taking other angiogenesis Inhibitors drugs for treating cancer.
• Other conditions not suitable for the current 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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai General Hospital, Shanghai Jiao Tong University — Шанхай

Идентификаторы

NCT: NCT05465252 · SXD20220608

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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