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

NCT05465252 | Recruiting

• 1 other identifier: SXD20220608
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Age-Related Macular Degeneration

Keywords

dry age-related macular degeneration; krill oil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Maximum Macular Drusen Height

  From enrollment to the end of follow-up at 3 months.

• Change in Best-Corrected Visual Acuity

  From enrollment to the end of follow-up at 3 months.

• Change in Self-Reported Visual Function

  From enrollment to the end of follow-up at 3 months.

Study Arms (2)

krill oil

EXPERIMENTAL

Dietary Supplement: Krill Oil

olive oil

PLACEBO COMPARATOR

Dietary Supplement: Olive Oil

Interventions

Olive Oil DIETARY_SUPPLEMENT

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.

olive oil

Krill Oil DIETARY_SUPPLEMENT

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.

Also known as: Superba Boost

krill oil

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital, Shanghai Jiao Tong University

Shanghai, 200080, China

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Xiaodong Sun, PHD

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huixun Jia, PhD

CONTACT

+86 18017317575; jiahuixun@163.com

Jiayu Xu

CONTACT

+86 18516200956; xujy_plusuuu@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: July 19, 2022
• Study Start: October 17, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)