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

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)

Serious Adverse Events
    Placebo/Control   Lutein/Zeaxanthin   DHA/EPA   Lutein/Zeaxanthin + DHA/EPA
Total, serious adverse events         
# participants affected / at risk   479/1012 (47.33%)   484/1044 (46.36%)   505/1068 (47.28%)   519/1079 (48.10%) 
Blood and lymphatic system disorders         
Blood and lymphatic system disorders * 1         
# participants affected / at risk   12/1012 (1.19%)   11/1044 (1.05%)   9/1068 (0.84%)   7/1079 (0.65%) 
# events   14   11   10   7 
Cardiac disorders         
Cardiac Disorders * 1         
# participants affected / at risk   96/1012 (9.49%)   110/1044 (10.54%)   119/1068 (11.14%)   103/1079 (9.55%) 
# events   122   138   144   133 
Congenital, familial and genetic disorders         
Congenital, familian and genetic disorders * 1         
# participants affected / at risk   3/1012 (0.30%)   1/1044 (0.10%)   0/1068 (0.00%)   0/1079 (0.00%) 
# events   3   1   0   0 
Ear and labyrinth disorders         
Ear and labyrinth disorders * 1         
# participants affected / at risk   7/1012 (0.69%)   3/1044 (0.29%)   4/1068 (0.37%)   1/1079 (0.09%) 
# events   7   3   4   1 
Endocrine disorders         
Endocrine disorders * 1         
# participants affected / at risk   2/1012 (0.20%)   3/1044 (0.29%)   3/1068 (0.28%)   0/1079 (0.00%) 
# events   2   3   3   0 
Eye disorders         
Eye disorders * 1         
# participants affected / at risk   3/1012 (0.30%)   11/1044 (1.05%)   4/1068 (0.37%)   0/1079 (0.00%) 
# events   3   13   6   0 
Gastrointestinal disorders         
Gastrointestinal disorders * 1         
# participants affected / at risk   76/1012 (7.51%)   69/1044 (6.61%)   58/1068 (5.43%)   61/1079 (5.65%) 
# events   101   81   72   71 
General disorders         
General disorders and administration site conditions * 1         
# participants affected / at risk   54/1012 (5.34%)   50/1044 (4.79%)   51/1068 (4.78%)   46/1079 (4.26%) 
# events   60   54   58   50 
Hepatobiliary disorders         
Hepatobiliary disorders * 1         
# participants affected / at risk   8/1012 (0.79%)   16/1044 (1.53%)   16/1068 (1.50%)   17/1079 (1.58%) 
# events   8   16   16   18 
Immune system disorders         
Immune system disorders * 1         
# participants affected / at risk   2/1012 (0.20%)   1/1044 (0.10%)   2/1068 (0.19%)   2/1079 (0.19%) 
# events   2   1   2   2 
Infections and infestations         
Infections and infestations * 1         
# participants affected / at risk   90/1012 (8.89%)   102/1044 (9.77%)   103/1068 (9.64%)   99/1079 (9.18%) 
# events   109   139   144   127 
Injury, poisoning and procedural complications         
Injury, poisoning and procedural complications * 1         
# participants affected / at risk   76/1012 (7.51%)   62/1044 (5.94%)   74/1068 (6.93%)   66/1079 (6.12%) 
# events   90   72   90   84 
Investigations         
Investigations * 1         
# participants affected / at risk   14/1012 (1.38%)   19/1044 (1.82%)   13/1068 (1.22%)   12/1079 (1.11%) 
# events   14   20   15   12 
Metabolism and nutrition disorders         
Metabolism and nutrition disorders * 1         
# participants affected / at risk   21/1012 (2.08%)   16/1044 (1.53%)   13/1068 (1.22%)   23/1079 (2.13%) 
# events   22   18   13   25 
Musculoskeletal and connective tissue disorders         
Musculoskeletal and connective tissue disorders * 1         
# participants affected / at risk   66/1012 (6.52%)   74/1044 (7.09%)   71/1068 (6.65%)   85/1079 (7.88%) 
# events   77   91   85   101 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Neoplasms benign, malignant and unspecified (incl cysts and polyps) * 1         
# participants affected / at risk   80/1012 (7.91%)   88/1044 (8.43%)   83/1068 (7.77%)   92/1079 (8.53%) 
# events   103   111   100   112 
Nervous system disorders         
Nervous system disorders * 1         
# participants affected / at risk   66/1012 (6.52%)   74/1044 (7.09%)   72/1068 (6.74%)   73/1079 (6.77%) 
# events   73   93   87   86 
Psychiatric disorders         
Psychiatric disorders * 1         
# participants affected / at risk   4/1012 (0.40%)   5/1044 (0.48%)   5/1068 (0.47%)   9/1079 (0.83%) 
# events   4   5   5   11 
Renal and urinary disorders         
Renal and urinary disorders * 1         
# participants affected / at risk   19/1012 (1.88%)   25/1044 (2.39%)   24/1068 (2.25%)   25/1079 (2.32%) 
# events   20   26   25   29 
Reproductive system and breast disorders         
Reproductive system and breast disorders * 1         
# participants affected / at risk   9/1012 (0.89%)   8/1044 (0.77%)   12/1068 (1.12%)   11/1079 (1.02%) 
# events   11   8   13   11 
Respiratory, thoracic and mediastinal disorders         
Respioratory, thoracic and mediastinal disorders * 1         
# participants affected / at risk   44/1012 (4.35%)   43/1044 (4.12%)   37/1068 (3.46%)   46/1079 (4.26%) 
# events   59   52   50   51 
Skin and subcutaneous tissue disorders         
Skin and subcutaneous tissue disorders * 1         
# participants affected / at risk   1/1012 (0.10%)   6/1044 (0.57%)   3/1068 (0.28%)   5/1079 (0.46%) 
# events   1   7   3   5 
Surgical and medical procedures         
Surgical and medical procedures * 1         
# participants affected / at risk   32/1012 (3.16%)   29/1044 (2.78%)   27/1068 (2.53%)   32/1079 (2.97%) 
# events   32   31   30   32 
Vascular disorders         
Vascular disorders * 1         
# participants affected / at risk   41/1012 (4.05%)   40/1044 (3.83%)   42/1068 (3.93%)   42/1079 (3.89%) 
# events   45   42   45   46 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (10.0)




  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.


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