Krill oil to slow progression of early and intermediate dry age-related macular degeneration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled trial comparing krill oil supplementation to an olive oil placebo in people with early or intermediate dry AMD defined by the Beckman Classification. Participants will take four capsules daily for three months, and investigators will compare retinal outcomes between groups after the treatment period. Eligible adults must stop other omega-3/choline/astaxanthin supplements before enrollment and attend follow-up visits during the study. The primary comparison is short-term structural or clinical differences after three months of supplementation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Shanghai General Hospital, Shanghai Jiao Tong University
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Xiaodong Sun, PHD — Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Study coordinator: Huixun Jia, PhD
• Email: jiahuixun@163.com
• Phone: +86 18017317575

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.