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NCT Number: NCT05465252

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

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai General Hospital, Shanghai Jiao Tong University

Shanghai, 200080, China

Location status: Recruiting

Location contact

Xiaodong Sun

CONTACT

+86-02163240090 ext. 6822

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Superba Boost

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.

Primary outcomes

  1. Change in Macular Drusen Volume

    Time frame: 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.

Secondary outcomes

  1. Change in Maximum Macular Drusen Height

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

    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.

  2. Change in Best-Corrected Visual Acuity

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

    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.

  3. Change in Self-Reported Visual Function

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huixun Jia, PhD

CONTACT

[email protected]

+86 18017317575

Jiayu Xu

CONTACT

[email protected]

+86 18516200956

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Acronym: OMEGA-AMD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 19, 2022
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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