Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Phase
Not applicable
Started
2025-10-17
Last updated
2026-01-02
Condition(s) studied
Age-Related Macular Degeneration
Investigational drug(s) / intervention(s)
Krill OilOlive Oil
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.
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.
Study summary
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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Change in Macular Drusen Volume — From enrollment to the end of follow-up at 3 months. Macular drusen volume will be quantified using spectral-domain optical coherence tomography (SD-OCT). Automated segmentation of Bruch's membrane and the retinal pigment epithelium (RPE), followed by manual verification, will be performed to calculate drusen volume at baseline and after 3 months of intervention at the same retinal location.
Change in macular drusen volume will be defined as the percentage change from baseline, calculated as the difference between post-intervention and baseline drusen volume divided by the baseline drusen volume.
Trial sites (1)
Facility
City
Region
Status
Shanghai General Hospital, Shanghai Jiao Tong University
Shanghai
China
Recruiting
More Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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