Age-Related Eye Disease Study 2 (AREDS2) (AREDS2)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00345176

First Posted: June 27, 2006

Last Update Posted: May 5, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

National Heart, Lung, and Blood Institute (NHLBI)

Office of Dietary Supplements (ODS)

National Center for Complementary and Integrative Health (NCCIH)

Information provided by (Responsible Party):

National Eye Institute (NEI)

Results First Submitted: November 1, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Conditions:	Age-related Macular Degeneration Cataract
Interventions:	Dietary Supplement: Lutein/zeaxanthin Dietary Supplement: DHA/EPA Drug: Lutein/zeaxanthin and DHA/EPA

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between October 2006 and September 2008 a total of 4,203 participants aged 50 - 85 years were randomized at 82 clinical sites.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomization, participants had to complete the Qualification phase. They could only be randomized if they took at least 75% of the run-in medication.

Reporting Groups

	Description
Placebo/Control	Considered control because all participants received the AREDS formulation
Lutein/Zeaxanthin	lutein (10mg)/zeaxanthin (2 mg)
DHA/EPA	DHA (350 mg)/EPA (650 mg)
Lutein/Zeaxanthin + DHA/EPA	lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)

Participant Flow: Overall Study

	Placebo/Control	Lutein/Zeaxanthin	DHA/EPA	Lutein/Zeaxanthin + DHA/EPA
STARTED	1012	1044	1068	1079
COMPLETED	1007	1038	1062	1069
NOT COMPLETED	5	6	6	10

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Placebo/Control	Considered control because all participants received the AREDS formulation
Lutein/Zeaxanthin	lutein (10mg)/zeaxanthin (2 mg)
DHA/EPA	DHA (350 mg)/EPA (650 mg)
Lutein/Zeaxanthin + DHA/EPA	lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
Total	Total of all reporting groups

Baseline Measures

	Placebo/Control	Lutein/Zeaxanthin	DHA/EPA	Lutein/Zeaxanthin + DHA/EPA	Total
Overall Participants Analyzed [Units: Participants]	1012	1044	1068	1079	4203

Age [Units: Participants] Median (Inter-Quartile Range)	74 (68 to 79)	74 (68 to 79)	74 (68 to 79)	75 (68 to 79)	74 (68 to 79)

Gender [Units: Participants]
Female	548	596	603	641	2388
Male	464	448	465	438	1815

Outcome Measures

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1. Primary:

Development of Advanced AMD in People at Moderate to High Risk for Progression. [ Time Frame: 5 years of follow-up ]

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2. Secondary:

Progression to Moderate Vision Loss [ Time Frame: 5 years of follow-up ]

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3. Secondary:

Adverse Events [ Time Frame: 5 years of follow-up ]

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4. Secondary:

Progression to Cataract Surgery [ Time Frame: 5 years of follow-up ]

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5. Other Pre-specified:

Incident Cardiovascular Disease [ Time Frame: 5 years of follow-up ]