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;   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 
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.  

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.  

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.  

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.  

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.  


  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 (70.85%)   791/1044 (75.77%)   759/1068 (71.07%)   791/1079 (73.31%) 
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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