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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Age-Related Macular Degeneration
• Intervention / Treatment: Dietary supplement: Krill Oil; Dietary supplement: Olive Oil

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huixun Jia, PhD; Phone Number: +86 18017317575; Email: jiahuixun@163.com
• Study Contact Backup: Name: Jiayu Xu; Phone Number: +86 18516200956; Email: xujy_plusuuu@sjtu.edu.cn

Study Locations

• China
  • Shanghai, China, 200080
    • Recruiting
    • Shanghai General Hospital, Shanghai Jiao Tong University
    • Contact: Xiaodong Sun; Phone Number: 6822 +86-02163240090

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: krill oil	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.; Other Names: Superba Boost
Placebo Comparator: olive oil	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Macular Drusen Volume	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.	From enrollment to the end of follow-up at 3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Maximum Macular Drusen Height	Maximum macular drusen height will be measured using SD-OCT at baseline and after 3 months of intervention. Change in maximum macular drusen height will be defined as the percentage change from baseline, calculated as the difference between post-intervention and baseline maximum drusen height divided by the baseline maximum drusen height.	From enrollment to the end of follow-up at 3 months.
Change in Best-Corrected Visual Acuity	Best-corrected visual acuity (BCVA) will be assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart and quantified as the total number of letters correctly identified by the participant. Change in BCVA will be defined as the absolute change in ETDRS letters from baseline, calculated as the difference between post-intervention and baseline measurements.	From enrollment to the end of follow-up at 3 months.
Change in Self-Reported Visual Function	Self-reported visual function will be assessed using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25). Change in self-reported visual function will be defined as the absolute change in NEI VFQ-25 total score from baseline, calculated as the difference between post-intervention and baseline scores.	From enrollment to the end of follow-up at 3 months.

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Xiaodong Sun, PhD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: dry age-related macular degeneration; krill oil
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Lipids; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Plant Oils; Oils; Dietary Fats; Fats; Dietary Fats, Unsaturated; Fats, Unsaturated; Olive Oil
• Other Study ID Numbers: SXD20220608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No