Krill oil to slow progression of early and intermediate dry age-related macular degeneration
Effect of Krill Oil Supplementation on Dry Age-Related Macular Degeneration: A Randomized Controlled Trial
This trial will test whether taking four krill oil capsules daily for three months can slow progression in adults with early or intermediate dry age-related macular degeneration.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05465252 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with early or intermediate dry AMD (Beckman classification), willing to stop other omega-3/choline/astaxanthin supplements and attend study visits, are the intended candidates.
Not a fit: Patients with advanced AMD (choroidal neovascularization or geographic atrophy), high myopia, other retinal diseases, recent relevant eye surgery, or those who cannot stop interfering supplements are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, krill oil supplementation might slow structural progression of dry AMD and help preserve vision or delay development of advanced disease.
How similar studies have performed: Large omega-3 trials such as AREDS2 did not show a clear benefit for preventing advanced AMD, and evidence specific to krill oil is limited and relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.