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 ]

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
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Time Frame 5 years
Additional Description Adverse events reported by System Organ Class

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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)

Other Adverse Events
    Placebo/Control     Lutein/Zeaxanthin     DHA/EPA     Lutein/Zeaxanthin + DHA/EPA  
Total, other (not including serious) adverse events          
# participants affected / at risk     717/1012     791/1044     759/1068     791/1079  
Eye disorders          
Dry eye † 1        
# participants affected / at risk     55/1012 (5.43%)     39/1044 (3.74%)     64/1068 (5.99%)     62/1079 (5.75%)  
# events     62     40     70     70  
Eye disorder † 1        
# participants affected / at risk     67/1012 (6.62%)     67/1044 (6.42%)     62/1068 (5.81%)     82/1079 (7.60%)  
# events     100     96     98     152  
Visual disturbance † 1        
# participants affected / at risk     88/1012 (8.70%)     110/1044 (10.54%)     84/1068 (7.87%)     88/1079 (8.16%)  
# events     118     139     116     119  
Vitreous disorder † 1        
# participants affected / at risk     133/1012 (13.14%)     154/1044 (14.75%)     165/1068 (15.45%)     162/1079 (15.01%)  
# events     208     213     228     208  
Gastrointestinal disorders          
Change in bowel habit † 1        
# participants affected / at risk     57/1012 (5.63%)     67/1044 (6.42%)     48/1068 (4.49%)     57/1079 (5.28%)  
# events     69     77     58     60  
Infections and infestations          
Bronchitis † 1        
# participants affected / at risk     62/1012 (6.13%)     69/1044 (6.61%)     57/1068 (5.34%)     56/1079 (5.19%)  
# events     72     83     80     66  
Upper respiratory tract infection † 1        
# participants affected / at risk     139/1012 (13.74%)     150/1044 (14.37%)     139/1068 (13.01%)     138/1079 (12.79%)  
# events     175     190     179     173  
Urinary tract infection † 1        
# participants affected / at risk     57/1012 (5.63%)     75/1044 (7.18%)     71/1068 (6.65%)     73/1079 (6.77%)  
# events     82     103     108     96  
Vascular disorders          
Hypertension † 1        
# participants affected / at risk     59/1012 (5.83%)     60/1044 (5.75%)     69/1068 (6.46%)     73/1079 (6.77%)  
# events     66     62     72     73  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (10.0)



  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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