NCT01653184

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

4 active sites

Status
completed

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

July 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

December 12, 2016

Status Verified

December 1, 2016

Enrollment Period

1.7 years

First QC Date

July 25, 2012

Last Update Submit

December 9, 2016

Conditions

Macular Degeneration

Keywords

AMDVision lossomega-3supplementage related macular degeneration

Outcome Measures

Primary Outcomes (1)

  • Change in omega-3 index

    To determine the change in omega-3 index using an omega-3 index serum test, in patients with dry AMD given the commercially available AREDS2 formula supplementation (containing 1gram of omega-3 fatty acids in ethyl ester formulation) compared to patients given a similar vitamin combination with 2 grams of omega-3 fatty acids.

    Monthly for 6 months

Study Arms (2)

Experimental: AREDS 2 Vitamin formula 1g

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

Dietary Supplement: Omega-3 fatty acid

Eye Omega Advantage 2g

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)

Dietary Supplement: Omega-3 fatty acid

Interventions

Omega-3 fatty acidDIETARY_SUPPLEMENT

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: AREDS 2 Vitamin formula 1gEye Omega Advantage 2g

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mid Atlantic Retina- Cherry Hill

Cherry Hill, New Jersey, 08002, United States

Location

Mid Atlantic Retina - Bethlehem

Bethlehem, Pennsylvania, 18020, United States

Location

Mid Atlantic Retina- Hungtindon Valley

Huntingdon Valley, Pennsylvania, 19006, United States

Location

Mid Atlantic Retina- Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Macular DegenerationVision Disorders

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Mitchell Fineman, MD

    Mid Atlantic Retina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2012

First Posted

July 30, 2012

Study Start

July 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

December 12, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

US(4)