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

Not Applicable

Not yet recruiting

• Conditions: Age-Related Macular Degeneration
• Interventions: Dietary Supplement: Krill Oil 500 MG; Dietary Supplement: Olive Oil 500MG

• Registration Number: NCT05465252
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-07-15
• Last Update Submitted: 2022-07-15
• Study First Posted: 2022-07-19
• Last Update Posted: 2022-07-19
• Study Start: 2022-08
• Primary Completion: 2023-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
krill oil	Krill Oil 500 MG	Subjects will take 3 capsules/1500mg of krill oil per day for 6 month
olive oil	Olive Oil 500MG	Subjects will take 3 capsules/1500mg of olive oil per day for 6 month

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
AE and SAE	6 months, 24 months	Change in number of Adverse Events
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.

Trial Locations

Locations (1)

Shanghai General Hospital, Shanghai Jiao Tong University; 🇨🇳 Shanghai, China