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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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
  Show All Outcome Measures

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
  Hide Serious Adverse Events

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
  Hide Limitations and Caveats

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