Aurora: Effect of Omega-3 Fatty Acid Supplementation on Dry-AMD Progression
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: krill oil Subjects will take 3 capsules/1500mg of krill oil per day for 6 month |
Dietary Supplement: Krill Oil 500 MG
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.
Other Names:
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| Placebo Comparator: olive oil Subjects will take 3 capsules/1500mg of olive oil per day for 6 month |
Dietary Supplement: Olive Oil 500MG
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.
|
Outcome Measures
Primary Outcome Measures
- The rate of 2-year progression-free [24 months]
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.
Secondary Outcome Measures
- Mean ETDRS BCVA at every visit [6 months, 24 months]
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.
- Mean central macular thickness by OCT at every visit [6 months, 24 months]
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.
- Intraocular Pressure [6 months, 24 months]
Eye pressure comparing to baseline in each group, respectively.
- Hematological Change in interleukin [6 months, 24 months]
Change in interleukin from baseline
- Hematological Change in monoamine oxidase [6 months, 24 months]
Change in monoamine oxidase from baseline
- Hematological Change in superoxide dismutase SOD [6 months, 24 months]
Change in superoxide dismutase SOD from baseline
- Hematological Change in Complement component 3 [6 months, 24 months]
Change in Complement component 3 from baseline
- Quality of life questionnaire (Visual Function Questionnaire 25) [6 months, 24 months]
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.
- AE and SAE [6 months, 24 months]
Change in number of Adverse Events
Eligibility Criteria
Criteria
Inclusion Criteria:
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Dry-AMD patients in either early, intermediate, or intermediate-to-late stage confirmed by fundus photography and FFA.
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Willing to stop supplementation of omega-3 fatty acids, choline, or astaxanthin.
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Willing to sign the informed consent, and willing to attend follow-up visits for at least 5 years.
Exclusion Criteria:
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Any eye with disease that would interfere with the fundus examinations
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Eye with CNV, GA or high myopia
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Surgeries that may interfere with AMD evaluation
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Long-term use of any medications that are associated with retinal or neural toxicities.
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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)
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Omega-3 index > 6
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Intraocular pressure more than 26 mmHg
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Received cataract surgery in 3 months.
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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.
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Other conditions not suitable for the current study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai General Hospital, Shanghai Jiao Tong University | Shanghai | China | 200080 |
Sponsors and Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
- Principal Investigator: Xiaodong Sun, PHD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SXD20220608