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

Age-Related Macular Degeneration Clinical Trial

— Aurora  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05465252
• Other study ID #: SXD20220608
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2022
• Est. completion date: December 2024

Study information

• Verified date: June 2022
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Huixun Jia, Master
• Phone: +86 18017317575
• Email: jiahuixun[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 330
• Est. completion date: December 2024
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Shanghai General Hospital, Shanghai Jiao Tong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Intraocular Pressure	Eye pressure comparing to baseline in each group, respectively.	6 months, 24 months
Secondary	Hematological Change in interleukin	Change in interleukin from baseline	6 months, 24 months
Secondary	Hematological Change in monoamine oxidase	Change in monoamine oxidase from baseline	6 months, 24 months
Secondary	Hematological Change in superoxide dismutase SOD	Change in superoxide dismutase SOD from baseline	6 months, 24 months
Secondary	Hematological Change in Complement component 3	Change in Complement component 3 from baseline	6 months, 24 months
Secondary	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
Secondary	AE and SAE	Change in number of Adverse Events	6 months, 24 months