Age-Related Eye Disease Study 2 (AREDS2)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT00345176
First received: June 14, 2006
Last updated: November 1, 2013
Last verified: November 2013
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
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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.
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  
Number of Participants  
[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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Measure Type Primary
Measure Title Development of Advanced AMD in People at Moderate to High Risk for Progression.
Measure Description Defined as central geographic atrophy or retinal features of choroidal neovascularization detected on central grading of the stereoscopic fundus photographs or a history of treatment for advanced AMD after study enrollment.
Time Frame 5 years of follow-up  
Safety Issue No  

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.
Intention to Treat. Participants lost to follow-up during the course of the study were censored at the time of last contact.

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)

Measured Values
    Placebo/Control     Lutein/Zeaxanthin     DHA/EPA     Lutein/Zeaxanthin + DHA/EPA  
Number of Participants Analyzed  
[units: participants]
  1007     1038     1062     1069  
Number of Eyes Analyzed  
[units: Eyes]
  1691     1709     1749     1742  
Development of Advanced AMD in People at Moderate to High Risk for Progression.  
[units: Eyes]
  493     468     507     472  


Statistical Analysis 1 for Development of Advanced AMD in People at Moderate to High Risk for Progression.
Groups [1] Placebo/Control vs. Lutein/Zeaxanthin
Method [2] Regression, Cox
P Value [3] <0.013
Hazard Ratio (HR) [4] 0.90
98.7% Confidence Interval ( 0.76 to 1.07 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Each of the 3 active arms was compared to the placebo/control arm.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Adjusted for baseline AMD status
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Adjusted for 3 treatment versus placebo comparisons and interim analyses
[4] Other relevant estimation information:
  The reference group is placebo.

Statistical Analysis 2 for Development of Advanced AMD in People at Moderate to High Risk for Progression.
Groups [1] Placebo/Control vs. DHA/EPA
Method [2] Regression, Cox
P Value [3] <0.013
Hazard Ratio (HR) [4] 0.97
98.7% Confidence Interval ( 0.82 to 1.16 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Adjusted for multiple comparisons
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Development of Advanced AMD in People at Moderate to High Risk for Progression.
Groups [1] Placebo/Control vs. Lutein/Zeaxanthin + DHA/EPA
Method [2] Regression, Cox
P Value [3] <0.013
Hazard Ratio (HR) [4] 0.89
98.7% Confidence Interval ( 0.75 to 1.06 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Adjusted for multiple comparisons
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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 ]


  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
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  More Information