Omega-3-fatty Acids on Age-related Macular

Aged Macular Degeneration Clinical Trial

— Omega 3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258335
• Other study ID #: 08-887
• Status: Completed
• Phase: N/A
• First received: December 9, 2010
• Last updated: November 21, 2011
• Start date: October 2008
• Est. completion date: November 2010

Study information

• Verified date: November 2011
• Source: Mid Atlantic Retina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Adnministration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aged Macular Degeneration
• Macular Degeneration

Intervention

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)

Other:
• Olive Oil
ii. Placebo oral daily (6 softgel capsules, each contains 1100 mg olive oil)

Locations

Country	Name	City	State
United States	Mid Atlantic Retina	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Mid Atlantic Retina	LifeGuard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No