Trial · NCT00345176

Age-Related Eye Disease Study 2 (AREDS2)

NCT00345176, Phase 3, Completed, National Eye Institute (NEI); results first posted 2013-12-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Age-Related Eye Disease Study 2 (AREDS2). Trials, record NCT00345176. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00345176

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Age-Related Eye Disease Study 2 (AREDS2)
NCT number: NCT00345176
Status: Completed
Phases: Phase 3
Enrollment: 4,203 participants, actual
Lead sponsor: National Eye Institute (NEI)
Conditions: Age-related Macular Degeneration, Cataract
Interventions: Lutein/zeaxanthin, DHA/EPA, Lutein/zeaxanthin and DHA/EPA
First posted: 2006-06-27
Last updated: 2015-05-05
Results first posted: 2013-12-24

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Development of Advanced AMD in People at Moderate to High Risk for Progression.	5 years of follow-up	Defined as central geographic atrophy or retinal features of choroidal neovascularization detected on central grading of the stereoscopic fundus photographs or a history of treatment for advanced AMD after study enrollment.
Secondary	Progression to Moderate Vision Loss	5 years of follow-up	Loss defined as \>/= 3 lines of letters from baseline or treatment for choroidal neovascularization
Secondary	Adverse Events	5 years of follow-up	Safety outcomes included serious adverse events and mortality.
Secondary	Progression to Cataract Surgery	5 years of follow-up	The study examined the effects of lutein/zeaxanthin on progression to cataract surgery with data collected during regular telephone contacts and the annual study visits.
Other	Incident Cardiovascular Disease	5 years of follow-up	Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin on cardiovascular disease
Other	Cognition as Measured by a Telephone Battery	5 years of follow-up	Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin, zinc, and beta-carotene on cognitive function
Other	Prevalence of Peripheral Changes as Measured Using OPTOS Imaging	5 years of follow-up	Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin on the peripheral retina
Other	Genetics for the Association of AMD and Cataract	5 years of follow-up
Other	Genetics for the Progression of AMD and Cataract	5 years of follow-up

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Development of Advanced AMD in People at Moderate to High Risk for Progression.	5 years of follow-up	Intention to Treat. Participants lost to follow-up during the course of the study were censored at the time of last contact.	Eyes	NUMBER
SECONDARY	Progression to Moderate Vision Loss	5 years of follow-up		Eyes	NUMBER
SECONDARY	Adverse Events	5 years of follow-up	Number of deaths in 5 years	Participants	NUMBER
SECONDARY	Progression to Cataract Surgery	5 years of follow-up	Includes participants who were phakic in at least 1 eye at baseline	Eyes	NUMBER
OTHER_PRE_SPECIFIED	Incident Cardiovascular Disease	5 years of follow-up
OTHER_PRE_SPECIFIED	Cognition as Measured by a Telephone Battery	5 years of follow-up
OTHER_PRE_SPECIFIED	Prevalence of Peripheral Changes as Measured Using OPTOS Imaging	5 years of follow-up
OTHER_PRE_SPECIFIED	Genetics for the Association of AMD and Cataract	5 years of follow-up
OTHER_PRE_SPECIFIED	Genetics for the Progression of AMD and Cataract	5 years of follow-up

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Development of Advanced AMD in People at Moderate to High Risk for Progression.	Placebo/Control		493	Eyes
Development of Advanced AMD in People at Moderate to High Risk for Progression.	Lutein/Zeaxanthin		468	Eyes
Development of Advanced AMD in People at Moderate to High Risk for Progression.	DHA/EPA		507	Eyes
Development of Advanced AMD in People at Moderate to High Risk for Progression.	Lutein/Zeaxanthin + DHA/EPA		472	Eyes
Progression to Moderate Vision Loss	Placebo/Control		515	Eyes
Progression to Moderate Vision Loss	Lutein/Zeaxanthin		509	Eyes
Progression to Moderate Vision Loss	DHA/EPA		519	Eyes
Progression to Moderate Vision Loss	Lutein/Zeaxanthin + DHA/EPA		506	Eyes
Adverse Events	Placebo/Control	Mortality	81	Participants
Adverse Events	Lutein/Zeaxanthin	Mortality	87	Participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo/Control	1,012
Overall Study	STARTED	Lutein/Zeaxanthin	1,044
Overall Study	STARTED	DHA/EPA	1,068
Overall Study	STARTED	Lutein/Zeaxanthin + DHA/EPA	1,079
Overall Study	COMPLETED	Placebo/Control	1,007
Overall Study	COMPLETED	Lutein/Zeaxanthin	1,038
Overall Study	COMPLETED	DHA/EPA	1,062
Overall Study	COMPLETED	Lutein/Zeaxanthin + DHA/EPA	1,069
Overall Study	NOT COMPLETED	Placebo/Control	5
Overall Study	NOT COMPLETED	Lutein/Zeaxanthin	6

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events132

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dry eye	Eye disorders	Placebo/Control	55	1,012	62
other	Dry eye	Eye disorders	Lutein/Zeaxanthin	39	1,044	40
other	Dry eye	Eye disorders	DHA/EPA	64	1,068	70
other	Dry eye	Eye disorders	Lutein/Zeaxanthin + DHA/EPA	62	1,079	70
other	Eye disorder	Eye disorders	Placebo/Control	67	1,012	100
other	Eye disorder	Eye disorders	Lutein/Zeaxanthin	67	1,044	96
other	Eye disorder	Eye disorders	DHA/EPA	62	1,068	98
other	Eye disorder	Eye disorders	Lutein/Zeaxanthin + DHA/EPA	82	1,079	152
other	Visual disturbance	Eye disorders	Placebo/Control	88	1,012	118
other	Visual disturbance	Eye disorders	Lutein/Zeaxanthin	110	1,044	139

1 to 10 of 132Source ClinicalTrials.gov

See all 132 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo/Control
Total, all-cause mortality	Lutein/Zeaxanthin
Total, all-cause mortality	DHA/EPA
Total, all-cause mortality	Lutein/Zeaxanthin + DHA/EPA
Total, other adverse events	Placebo/Control	717	1,012
Total, other adverse events	Lutein/Zeaxanthin	791	1,044
Total, other adverse events	DHA/EPA	759	1,068
Total, other adverse events	Lutein/Zeaxanthin + DHA/EPA	791	1,079
Total, serious adverse events	Placebo/Control	479	1,012
Total, serious adverse events	Lutein/Zeaxanthin	484	1,044

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers13

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
18421079	DERIVED	PubMed
22879423	DERIVED	PubMed
23620429	DERIVED	PubMed
23644932	DERIVED	PubMed
23645227	DERIVED	PubMed
23830564	DERIVED	PubMed
23887802	DERIVED	PubMed
24310343	DERIVED	PubMed
24638908	DERIVED	PubMed
26305649	DERIVED	PubMed

1 to 10 of 13

See all 13 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00345176

GET https://conductscience.org/api/trials/v1/NCT00345176/events?page=2

API reference For AI assistants