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

Primary Purpose

Age-Related Macular Degeneration

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Krill Oil 500 MG
Olive Oil 500MG
Sponsored by
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring dry age-related macular degeneration, krill oil

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai General Hospital, Shanghai Jiao Tong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

krill oil

olive oil

Arm Description

Subjects will take 3 capsules/1500mg of krill oil per day for 6 month

Subjects will take 3 capsules/1500mg of olive oil per day for 6 month

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Intraocular Pressure
Eye pressure comparing to baseline in each group, respectively.
Hematological Change in interleukin
Change in interleukin from baseline
Hematological Change in monoamine oxidase
Change in monoamine oxidase from baseline
Hematological Change in superoxide dismutase SOD
Change in superoxide dismutase SOD from baseline
Hematological Change in Complement component 3
Change in Complement component 3 from baseline
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.
AE and SAE
Change in number of Adverse Events

Full Information

First Posted
June 9, 2022
Last Updated
July 15, 2022
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05465252
Brief Title
Effect of Omega-3 Fatty Acid Supplementation on Dry-AMD Progression
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
dry age-related macular degeneration, krill oil

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
krill oil
Arm Type
Experimental
Arm Description
Subjects will take 3 capsules/1500mg of krill oil per day for 6 month
Arm Title
olive oil
Arm Type
Placebo Comparator
Arm Description
Subjects will take 3 capsules/1500mg of olive oil per day for 6 month
Intervention Type
Dietary Supplement
Intervention Name(s)
Krill Oil 500 MG
Other Intervention Name(s)
Superba Boost
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Olive Oil 500MG
Intervention Description
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.
Primary Outcome Measure Information:
Title
The rate of 2-year progression-free
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Mean ETDRS BCVA at every visit
Description
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.
Time Frame
6 months, 24 months
Title
Mean central macular thickness by OCT at every visit
Description
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.
Time Frame
6 months, 24 months
Title
Intraocular Pressure
Description
Eye pressure comparing to baseline in each group, respectively.
Time Frame
6 months, 24 months
Title
Hematological Change in interleukin
Description
Change in interleukin from baseline
Time Frame
6 months, 24 months
Title
Hematological Change in monoamine oxidase
Description
Change in monoamine oxidase from baseline
Time Frame
6 months, 24 months
Title
Hematological Change in superoxide dismutase SOD
Description
Change in superoxide dismutase SOD from baseline
Time Frame
6 months, 24 months
Title
Hematological Change in Complement component 3
Description
Change in Complement component 3 from baseline
Time Frame
6 months, 24 months
Title
Quality of life questionnaire (Visual Function Questionnaire 25)
Description
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.
Time Frame
6 months, 24 months
Title
AE and SAE
Description
Change in number of Adverse Events
Time Frame
6 months, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huixun Jia, Master
Phone
+86 18017317575
Email
jiahuixun@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Junran Sun, M.D.
Phone
+86 13661995933
Email
emiliesun@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaodong Sun, PHD
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai General Hospital, Shanghai Jiao Tong University
City
Shanghai
ZIP/Postal Code
200080
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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