Evidence map›Paper›PMID 22840421›Full record

Trial reportOphthalmology2012

The Age-Related Eye Disease Study 2 (AREDS2): study design and baseline characteristics (AREDS2 report number 1).

AREDS2 Research Group, Emily Y Chew, Traci Clemons, John Paul SanGiovanni, Ronald Danis, Amitha Domalpally, Wendy McBee, Robert Sperduto, Frederick L Ferris

6 registry-linked trialsAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Ophthalmology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 214 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
214citing papers in PubMed, 9 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01915238 completednot on this mapstarted 2013, after this paper: background citation

Age-Related Eye Disease Study 2 (AREDS2) Ancillary Spectral Domain Optical Coherence Tomography (A2A_SDOCT) Extension Study

TypeobservationalSponsorNational Eye Institute (NEI)Ran2013 to 2014Enrolled52ConditionsAMD, Age- Related Macular Degeneration
NCT03712670 nacompletednot on this mapstarted 2016, after this paper: background citation

Treatment of Exudative Age-Related Macular Degeneration With Aflibercept Combined With Pranoprofen Eye Drops or Nutraceutical Support With Omega-3: A Randomized Trial

TypeinterventionalSponsorUniversità degli Studi di BresciaRan2016 to 2017Enrolled60ConditionsRetinal DiseaseArmsAflibercept, Pranoprofen, Carotenoids
NCT05062486 phase2completednot on this mapstarted 2021, after this paper: background citation

An Open-Label, Randomized, Double Arm, Phase 2 Study to Evaluate the Safety and Efficacy of C and RQC for Preventing Progression in Age-Related Macular Degeneration

TypeinterventionalSponsorPaul A Knepper, MD PhDRan2021 to 2024Enrolled55ConditionsAge-related Macular DegenerationArmsResveratrol, Quercetin, Curcumin (RQC), Curcumin
NCT06518512 active not recruitingnot on this mapstarted 2023, after this paper: background citation

Automated Vision Assessment and Impairment Detection Through Gaze Analysis in Wet Age Related Macular Degeneration (AMD) Patients: a Prospective Clinical Evaluation (AVIGA2)

TypeobservationalSponsorTan Tock Seng HospitalRan2023 to 2026Enrolled128ConditionsAge-Related Macular Degeneration, Wet Age-related Macular DegenerationArmsAutomated Vision Assessment and Impairment Detection through Gaze Analysis (AVIGA) system
NCT07255885 completednot on this mapstarted 2025, after this paper: background citation

CRYSTALSIGHT: ''Cohort 1.5" Clinical Investigation Study With OCCUTRACK and Tan Tock Seng Eye Clinic to Further Develop Remote Monitoring of Maculopathy at Home Using Artificial Intelligence for Eye Tracking

TypeobservationalSponsorTan Tock Seng HospitalRan2025 to 2025Enrolled20ConditionsMaculopathy, Maculopathy, Age Related, Macular Degeneration, Age-Related, Diabetic RetinopathyArmsCRYSTALSIGHT Test
NCT07338513 not yet recruitingnot on this mapstarted 2026, after this paper: background citation

User-centric Study of Patients' Receptiveness Towards the Web-based Automated Vision Impairment Gaze-tracking Analysis Systems

TypeobservationalSponsorTan Tock Seng HospitalRan2026 to 2027Enrolled30ConditionsAge-Related Macular Degeneration, Wet Age-related Macular Degeneration
3 · Its place in the literature

Who cites it

214 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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154 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

AREDS2 Research GroupDivision of Epidemiology and Clinical Applications, National Eye Institute/National Institutes of Health, Bethesda, Maryland, USA. echew@nei.nih.gov
Emily Y Chew
Traci Clemons
John Paul SanGiovanni
Ronald Danis
Amitha Domalpally
Wendy McBee
Robert Sperduto
Frederick L Ferris

Funding

The Age-Related Eye Disease Study 2 (AREDS2)ZIAEY000485 · NEI · NATIONAL EYE INSTITUTE · PI CHEW, EMILY Y · 2009 to 2015
$990k
Intramural NIH HHS ZIA EY000485NEI NIH HHS N01-EY-5-0007
6 · The paper itself

Abstract

purposeThe Age-Related Eye Disease Study (AREDS) demonstrated beneficial effects of oral supplementation with antioxidant vitamins and minerals on the development of advanced age-related macular degeneration (AMD) in persons with at least intermediate AMD (bilateral large drusen with or without pigment changes). Observational data suggest that other oral nutrient supplements might further reduce the risk of progression to advanced AMD. The primary purpose of the Age-Related Eye Disease Study 2 (AREDS2) is to evaluate the efficacy and safety of lutein plus zeaxanthin (L+Z) and/or ω-3 long-chain polyunsaturated fatty acid (LCPUFA) supplementation in reducing the risk of developing advanced AMD. The study also assesses the reduction in zinc and the omission of β-carotene from original AREDS formulation.

designMulticenter, phase III, randomized, controlled clinical trial.

participantsPersons aged 50 to 85 with bilateral intermediate AMD or advanced AMD in 1 eye.

methodsAll participants were randomly assigned to placebo (n = 1012), L+Z (10 mg/2 mg; n = 1044), ω-3 LCPUFAs (eicosapentaenoic acid + docosahexaenoic acid [650 mg/350 mg]; n = 1069), or the combination of L+Z and ω-3 LCPUFAs (n = 1078). All participants were offered a secondary randomization to 1 of 4 variations of the original AREDS formulation keeping vitamins C (500 mg) and E (400 IU) and copper (2 mg) unchanged while varying zinc and β-carotene as follows: Zinc remains at the original level (80 mg), lower only zinc to 25 mg, omit β-carotene only, or lower zinc to 25 mg and omit β-carotene.

main outcome measuresProgression to advanced AMD determined by centralized grading of annual fundus photographs.

resultsWe enrolled 4203 participants at 82 clinical centers located in the United States. Population characteristics at baseline were as follows: Mean age, 74 years; 57% female; 97% white; 7% current smokers; 19% with prior cardiovascular disease; and 44% and 50% taking statin-class cholesterol-lowering drugs and aspirin, respectively. Ocular characteristics include 59% with bilateral large drusen, 32% with advanced AMD in 1 eye and mean visual acuity of 20/32 in eyes without advanced AMD.

conclusionsThis report presents the AREDS2 study design and the participants' baseline demographic and ocular characteristics.

Indexed as

AgedAged, 80 and overDietary SupplementsDisease ProgressionDocosahexaenoic AcidsDrug Therapy, CombinationEicosapentaenoic AcidEpidemiologic MethodsFatty Acids, Omega-3FemaleHumansLuteinMacular DegenerationMaleMiddle AgedResearch DesignDocosahexaenoic AcidsEicosapentaenoic AcidFatty Acids, Omega-3LuteinXanthophyllsZeaxanthins

Identifiers

PMID22840421
PMCPMC3485447

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.