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

This study has been completed.
Sponsor:
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)
ClinicalTrials.gov Identifier:
NCT00345176
First received: June 14, 2006
Last updated: April 13, 2015
Last verified: April 2015
Results First Received: November 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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


  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.
No text entered.

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 ]

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

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

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

5.  Other Pre-specified:   Incident Cardiovascular Disease   [ Time Frame: 5 years of follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Other Pre-specified:   Cognition as Measured by a Telephone Battery   [ Time Frame: 5 years of follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Other Pre-specified:   Prevalence of Peripheral Changes as Measured Using OPTOS Imaging   [ Time Frame: 5 years of follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Other Pre-specified:   Genetics for the Association of AMD and Cataract   [ Time Frame: 5 years of follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Other Pre-specified:   Genetics for the Progression of AMD and Cataract   [ Time Frame: 5 years of follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information