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

Study Overview
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Brief Summary
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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

Official Title
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Effect of Omega-3 Fatty Acid (Krill Oil, 500 mg, Including EPA 60 mg and DHA 27.5 mg, Total Phospholipid 200 mg, Astaxanthin 50 µg) Supplementation on Dry-AMD Progression

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Dietary Supplement: Krill Oil 500 MG
* Dietary Supplement: Olive Oil 500MG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: krill oil<br>Subjects will take 3 capsules/1500mg of krill oil per day for 6 month | Dietary Supplement: Krill Oil 500 MG<br>* Qualified subjects start to take supplementation from Day 1 in the trial. Specifically, subjects from Intervention group take 3 capsules of krill oil per day.<br>* Other names: Superba Boost;|
| Placebo Comparator: olive oil<br>Subjects will take 3 capsules/1500mg of olive oil per day for 6 month | Dietary Supplement: Olive Oil 500MG<br>* Qualified subjects start to take placebo from Day 1 in the trial. Specifically, subjects from placebo group take 3 capsules of olive oil , which has the same color and smell as the krill oil.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of 2-year progression-free | The evaluation criteria for progression: progress to intermediate (only for patients with early phase AMD at baseline) or intermediate-to-late, or late stage AMD. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean ETDRS BCVA at every visit | Compare of mean ETDRS Best-Corrected-visual-acuity at every visit or treatment. （number of letters） between the two groups comparing to baseline to assess the efficacy of krill oil. | 6 months, 24 months | 
| Mean central macular thickness by OCT at every visit | Compare of mean mean central macular thickness （mm） by OCT at every visit or treatment between the two groups comparing to baseline to assess the efficacy of krill oil. | 6 months, 24 months | 
| Intraocular Pressure | Eye pressure comparing to baseline in each group, respectively. | 6 months, 24 months | 
| Hematological Change in interleukin | Change in interleukin from baseline | 6 months, 24 months | 
| Hematological Change in monoamine oxidase | Change in monoamine oxidase from baseline | 6 months, 24 months | 
| Hematological Change in superoxide dismutase SOD | Change in superoxide dismutase SOD from baseline | 6 months, 24 months | 
| Hematological Change in Complement component 3 | Change in Complement component 3 from baseline | 6 months, 24 months | 
| Quality of life questionnaire (Visual Function Questionnaire 25) | Change in score of Visual Function Questionnaire 25 from baseline. The 25-item questionnaire gives a score on a scale of 0 to 100 points. A score of 0 is the worst score, and a score of 100 is the best score and means the patient has no vision problems. | 6 months, 24 months | 
| AE and SAE | Change in number of Adverse Events | 6 months, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry age-related macular degeneration, krill oil