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

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Age-Related Macular Degeneration

Treatments: Dietary Supplement: Olive Oil 500MG; Dietary Supplement: Krill Oil 500 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05465252

SXD20220608

Details and patient eligibility

About

This multi-center, randomized, double-blind (subjects and doctors), placebo controlled study will evaluate the effect of krill oil on dry-AMD progression. The pilot study will observe biochemical and hematologic biomarkers changes after 3-month treatment between the krill oil group and placebo group

Enrollment: 330 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Dry-AMD patients in either early, intermediate, or intermediate-to-late stage confirmed by fundus photography and FFA.
• 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 5 years.

Exclusion criteria

• Any eye with disease that would interfere with the fundus examinations
• Eye with CNV, 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.
• Supplementation history with more than 2 mg lutein or 500 mg omega-3 fatty acid/day s (can be included if wash-out phase for 8 weeks before the trial)
• Omega-3 index > 6
• Intraocular pressure more than 26 mmHg
• Received cataract surgery in 3 months.
• Other conditions: diseases that causes less than 5 years survival; 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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330 participants in 2 patient groups, including a placebo group

krill oil

Experimental group

Description:

Subjects will take 3 capsules/1500mg of krill oil per day for 6 month

Treatment:

Dietary Supplement: Krill Oil 500 MG

olive oil

Placebo Comparator group

Description:

Subjects will take 3 capsules/1500mg of olive oil per day for 6 month

Treatment:

Dietary Supplement: Olive Oil 500MG