Effect of Omega-3 Fatty Acid Supplementation on Dry-AMD Progression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Krill Oil, Olive Oil.
- Who it may be relevant to
- Registry conditions: Age-Related Macular Degeneration. Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Krill Oil Supplementation on Dry Age-Related Macular Degeneration: A Randomized Controlled Trial
Overview
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.
Interventions
- Dietary supplement 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. - Dietary supplement 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.
Primary outcome measures
- Change in Macular Drusen Volume [Time frame: From enrollment to the end of follow-up at 3 months.]
Secondary outcome measures (3)
- Change in Maximum Macular Drusen Height [Time frame: From enrollment to the end of follow-up at 3 months.]
- Change in Best-Corrected Visual Acuity [Time frame: From enrollment to the end of follow-up at 3 months.]
- Change in Self-Reported Visual Function [Time frame: From enrollment to the end of follow-up at 3 months.]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai General Hospital, Shanghai Jiao Tong University — Shanghai
Identifiers
NCT: NCT05465252 · SXD20220608