Omega-3-fatty Acids on Age-related Macular (Omega 3)

November 21, 2011 updated by: Mid Atlantic Retina

Short Term Ocular Safety Assessment of High Dose Omega-3 Supplementation for Age-Related Macular Degeneration.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is a growing amount of basic science data supporting the use of omega 3 fatty acids in AMD. Koto et al. report that eicosapentaenoic acid, a major omega-3 polyunsaturated fatty acid, prevents CNVM in mice. Conner et al. report in Nature Medicine that increased dietary intake of omega-3-polyunsaturated fatty acids reduces pathological retinal angiogenesis in mice. Miyauchi et al. looked at ERG outcomes in rabbits. They report that an intraperitoneal injection of docosahexaenoic acid given 5 hours before IOP induced ischemia resulted in better ERG amplitudes than controls. Docosahexaenoic acid appears to protect against transient retinal ischemia.

Clinical data on this topic is scarce. A systemic review was published in Retina in 2007 (Hodge, et al.) outlining the limited data. A recent meta-analysis by Chong et al. of nine studies found a high dietary intake of omega-3 fatty acids decreased risk of late AMD by 38%, though the current literature is insufficient to support routine consumption to prevent AMD. Scorolli et al. conducted a randomized control trial on 35 bilateral wet AMD patients receiving photodynamic therapy with our without vitamin E, linolenic acid, alpha-linolenic acid, and docosahexaenoic acid (DHA). The latter two are omega-3-fatty acids. Patients in the polyunsaturated fatty acid (PUFA) group had significantly shorter recovery time after macular flash. Visually acuity was not statistically different between the two groups. Feher et al. conducted a randomized control trial using acetyl-L-carnitine, omega-3 fatty acids, and coenzyme Q10 (Phototrop). They report findings that strongly suggest that an appropriate combination of compounds that affect mitochondrial lipid metabolism may improve and subsequently stabilize visual functions, and it may also improve fundus alterations in patients affected by early AMD. The Blue Mountain Eye Study, a cohort study, reports a regular diet high in omega-3 polyunsaturated fat, especially from fish, seems to protect against early and late ARM. Seddon et al. performed a clinic-based case-control study across five centers, concluding diets high in omega-3 fatty acids and fish are inversely associated with risk for AMD when intake of linoleic acid was low. Augood et al. published a cross-sectional study of 105 cases, reporting eating oily fish at least once per week compared with less than once per week decreased the odds ratio for neovascular AMD by half.

Few authors have evaluated the role of ERG in treating AMD. A recent review by Gerth concludes ERG is an important tool in assessing retinal function in AMD and as an outcome measure. Multifocal ERG, possibly combined with other tests, has the greatest value. Hishihara et al. have evaluated the amplitude and implicit time changes in neovascular AMD using focal macular ERGs.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Mid Atlantic Retina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

i. >49 year old women and men for the dry AMD arms. >20 year old for the normal retina arm.

1. No specific race/ethnic background requirements

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Omega 3 Fatty acids

II. 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)
Dietary supplement: Omega 3
Omega-3-fatty acids 4 gm oral daily (Total:840mg EPA/2520mg DHA) (1:3 ratio of EPA to DHA) ( 6 capsules fatty acids)
PLACEBO_COMPARATOR: Olive Oil
ii. Placebo oral daily (6 softgel capsules, each contains 1100 mg olive oil)
Other: Olive Oil
ii. Placebo oral daily (6 softgel capsules, each contains 1100 mg olive oil)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Omega 3
Time Frame: 6 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mid Atlantic Retina

Collaborators

LifeGuard

Investigators

  • Principal Investigator: Allen Ho, MD, Retina Specialist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

December 9, 2010

First Submitted That Met QC Criteria

December 9, 2010

First Posted (ESTIMATE)

December 10, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 22, 2011

Last Update Submitted That Met QC Criteria

November 21, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-887

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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