Overview

This trial is active, not recruiting.

Condition macular degeneration
Treatment omega-3 fatty acid
Sponsor Wills Eye
Collaborator Physician Recommended Nutriceuticals
Start date July 2012
End date March 2014
Trial size 100 participants
Trial identifier NCT01653184, Omega 20120660, Protocol #20120660

Summary

The effect of omega-3-fatty acids on blood levels omega-3 fatty acids in patients with age-related macular degeneration.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients will receive oral supplementation with the commercially available "AREDS2" vitamin formula (PreserVision AREDS 2 Eye Vitamin and Mineral Supplement. Bausch + Lomb Incorporated), consisting of vitamins C, E, zinc, lutein, zeaxanthin and 1g of omega-3 fatty acids in the ethyl ester formulation
omega-3 fatty acid
The purpose of our study is to evaluate the change in serum omega-3 index (blood level of omega-3 fatty acids) after 1 gram of omega-3 fatty acid supplementation versus 2 grams.
(Experimental)
Patients will receive a similar vitamin combination in the second arm (Eye Omega Advantage® and Macular Vitamin Benefit. Physician Recommended Nutriceuticals) with 2g of omega-3 fatty acids in the triglyceride formulation (see attached document for supplement details)
omega-3 fatty acid
The purpose of our study is to evaluate the change in serum omega-3 index (blood level of omega-3 fatty acids) after 1 gram of omega-3 fatty acid supplementation versus 2 grams.

Primary Outcomes

Measure
Change in omega-3 index
time frame: Monthly for 6 months

Eligibility Criteria

Male or female participants at least 55 years old.

Inclusion Criteria: - Ability to provide written informed consent and comply with study assessments for the full duration of the study. - Have AREDS category 3 or 4 disease. - Category 3: Many medium sized drusen or one or more large drusen in one or both eyes - Category 4: Geographic atrophy or choroidal neovascularization in one eye. Exclusion Criteria: - Women of child-bearing age with positive urine pregnancy tests or desire to conceive during the course of the study. - Patients with a known fish allergy. - Patients currently taking supplementation with omega-3 fatty acids and have an omega-3 index of greater than 4%.

Additional Information

Official title The Effect of Oral Supplementation With Omega-3 Fatty Acids on Serum Omega-3 Levels in Patients With Age-related Macular Degeneration: A Randomized Controlled Trial.
Principal investigator Mitchell Fineman, MD
Description There is observational data in the current literature suggesting that the intake of foods high in marine sources of omega-3 fatty acids, such as fish, may lower the risk of developing age-related macular degeneration (AMD). A large prospective study is underway to determine whether oral supplementation with 1 gram of omega-3 fatty acids is beneficial for subjects with dry AMD. The purpose of our study is to evaluate the change in serum omega-3 index (blood level of omega-3 fatty acids) after 1 gram of omega-3 fatty acid supplementation versus 2 grams.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Wills Eye.