Clinical trial NCT05465252: Effect of Omega-3 Fatty Acid Supplementation on Dry-AMD Progression
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Age-Related Macular Degeneration
Keywords: dry age-related macular degeneration
krill oil
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 330
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: The rate of 2-year progression-free
timeFrame: 24 months
Secondary outcomes:
measure: Mean ETDRS BCVA at every visit
timeFrame: 6 months, 24 months
measure: Mean central macular thickness by OCT at every visit
timeFrame: 6 months, 24 months
measure: Intraocular Pressure
timeFrame: 6 months, 24 months
measure: Hematological Change in interleukin
timeFrame: 6 months, 24 months
measure: Hematological Change in monoamine oxidase
timeFrame: 6 months, 24 months
measure: Hematological Change in superoxide dismutase SOD
timeFrame: 6 months, 24 months
measure: Hematological Change in Complement component 3
timeFrame: 6 months, 24 months
measure: Quality of life questionnaire (Visual Function Questionnaire 25)
timeFrame: 6 months, 24 months
measure: AE and SAE
timeFrame: 6 months, 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital, Shanghai Jiao Tong University
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Xiaodong Sun, PHD
role: PRINCIPAL_INVESTIGATOR
References: