Omega-3-fatty Acids on Age-related Macular
Omega 3
Short Term Ocular Safety Assessment of High Dose Omega-3 Supplementation for Age-Related Macular Degeneration.
1 other identifier
interventional
25
1 country
1
Brief Summary
Aim: To demonstrate the short-term multi focal electroretinogram (mfERG) effect of oral omega-3-fatty acids in the triglyceride form on dry age-related macular degeneration (AMD). Null hypothesis: Omega-3-fatty acids do not affect the mfERGs of patients with dry AMD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 9, 2010
CompletedFirst Posted
Study publicly available on registry
December 10, 2010
CompletedNovember 22, 2011
November 1, 2011
2.1 years
December 9, 2010
November 21, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Omega 3
Aim: To demonstrate the short-term multi focal electroretinogram (mfERG) effect of oral omega-3-fatty acids in the triglyceride form on dry age-related macular degeneration (AMD). Null hypothesis: Omega-3-fatty acids do not affect the mfERGs of patients with dry AMD.
6 months
Study Arms (2)
Omega 3 Fatty acids
ACTIVE COMPARATORII. Study arms: a. Participants in the dry AMD study group will be randomized into two arms with a 4:1 ratio: i. Omega-3-fatty acids 4 gm oral daily (Total:840mg EPA/2520mg DHA) (1:3 ratio of EPA to DHA) ( 6 capsules fatty acids)
Olive Oil
PLACEBO COMPARATORii. Placebo oral daily (6 softgel capsules, each contains 1100 mg olive oil)
Interventions
Eligibility Criteria
You may qualify if:
- i. \>49 year old women and men for the dry AMD arms. \>20 year old for the normal retina arm.
- \. No specific race/ethnic background requirements
You may not qualify if:
- i. For dry AMD groups, all patients will be included, regardless of prior or concomitant treatment, and regardless of stage of disease.
- ii. Patients already taking omega-3-fatty acids will be excluded. iii. Women of childbearing age with positive urine pregnancy tests or with plans to conceive during the six month study period will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mid Atlantic Retinalead
- LifeGuardcollaborator
Study Sites (1)
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107, United States
Related Publications (1)
Gerstenblith AT, Baskin DE, Shah CP, Wolfe JD, Fineman MS, Kaiser RS, Ho AC. Electroretinographic effects of omega-3 Fatty Acid supplementation on dry age-related macular degeneration. JAMA Ophthalmol. 2013 Mar;131(3):365-9. doi: 10.1001/jamaophthalmol.2013.642.
PMID: 23494041DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allen Ho, MD
Retina Specialist
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 9, 2010
First Posted
December 10, 2010
Study Start
October 1, 2008
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
November 22, 2011
Record last verified: 2011-11