Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Age-Related Eye Disease Study 2 (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: November 1, 2013
Last verified: November 2013
History of Changes
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 ]
  Show Outcome Measure 1

2.  Secondary:   Progression to Moderate Vision Loss   [ Time Frame: 5 years of follow-up ]
  Show Outcome Measure 2

3.  Secondary:   Adverse Events   [ Time Frame: 5 years of follow-up ]
  Show Outcome Measure 3

4.  Secondary:   Progression to Cataract Surgery   [ Time Frame: 5 years of follow-up ]
  Show Outcome Measure 4


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show 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
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Traci Clemons, PhD
Organization: The EMMES Corporation
phone: 301-251-1161 ext 212
e-mail: tclemons@emmes.com


No publications provided by National Eye Institute (NEI)

Publications automatically indexed to this study:


Responsible Party: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT00345176     History of Changes
Obsolete Identifiers: NCT00409513
Other Study ID Numbers: NEI-120, N01-EY-5-0007, HHS-N-260-2005-00007-C, CC-070025, 07-EI-0025
Study First Received: June 14, 2006
Results First Received: November 1, 2013
Last Updated: November 1, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration