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

Shanghai Jiao Tong University

Status

Enrolling

Conditions

Age-Related Macular Degeneration

Treatments

Dietary Supplement: Krill Oil

Dietary Supplement: Olive Oil

Study type

Interventional

Funder types

Other

Identifiers

NCT05465252

SXD20220608

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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.