Age-Related Eye Disease Study (AREDS)

NCT00000145 | Completed Phase 3 DMC

• 1 other identifier: NEI-44
• Study Type: interventional
• Target: 4,757
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the clinical course, prognosis, and risk factors of age-related macular degeneration (AMD) and cataract. To evaluate, in randomized clinical trials, the effects of pharmacologic doses of (1) antioxidants and zinc on the progression of AMD and (2) antioxidants on the development and progression of lens opacities.

Conditions

Macular Degeneration; Cataract; Lens Opacities

Keywords

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• Progression of age-related macular degeneration

• Progression of lens opacity (cataract)

Study Arms (4)

1

EXPERIMENTAL

Antioxidants

Dietary Supplement: Antioxidants

2

EXPERIMENTAL

Zinc

Dietary Supplement: Zinc

3

EXPERIMENTAL

Antioxidants and zinc

Dietary Supplement: Antioxidants and zinc

4

NO INTERVENTION

Interventions

Antioxidants DIETARY_SUPPLEMENT

500 milligrams vitamin C; 400 IUs vitamin E; 15 milligrams beta-carotene

1

Zinc DIETARY_SUPPLEMENT

80 milligrams zinc oxide; 2 milligrams of cupric oxide

2

Antioxidants and zinc DIETARY_SUPPLEMENT

500 milligrams vitamin C; 400 IUs vitamin E; 15 milligrams beta-carotene; 80 milligrams zinc oxide; 2 milligrams of cupric oxide

3

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Men and women between the ages of 55 and 80 years whose macular status ranges from no evidence of AMD in either eye to relatively severe disease with vision loss in one eye but good vision in the fellow eye (20/30 or better) are eligible for the study provided that their ocular media are clear enough to allow good fundus photography.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Eye Institute (NEI): lead
• Bausch & Lomb Incorporated: collaborator

Related Publications (28)

• Age-Related Eye Disease Study Research Group. The Age-Related Eye Disease Study system for classifying age-related macular degeneration from stereoscopic color fundus photographs: the Age-Related Eye Disease Study Report Number 6. Am J Ophthalmol. 2001 Nov;132(5):668-81. doi: 10.1016/s0002-9394(01)01218-1.

  PMID: 11704028 BACKGROUND

• Age-Related Eye Disease Study Research Group. The age-related eye disease study (AREDS) system for classifying cataracts from photographs: AREDS report no. 4. Am J Ophthalmol. 2001 Feb;131(2):167-75. doi: 10.1016/s0002-9394(00)00732-7.

  PMID: 11228291 BACKGROUND

• Age-Related Eye Disease Study Research Group. The Age-Related Eye Disease Study (AREDS): design implications. AREDS report no. 1. Control Clin Trials. 1999 Dec;20(6):573-600. doi: 10.1016/s0197-2456(99)00031-8.

  PMID: 10588299 BACKGROUND

• Clemons TE, Chew EY, Bressler SB, McBee W; Age-Related Eye Disease Study Research Group. National Eye Institute Visual Function Questionnaire in the Age-Related Eye Disease Study (AREDS): AREDS Report No. 10. Arch Ophthalmol. 2003 Feb;121(2):211-7. doi: 10.1001/archopht.121.2.211.

  PMID: 12583787 BACKGROUND

• Bressler NM, Bressler SB, Congdon NG, Ferris FL 3rd, Friedman DS, Klein R, Lindblad AS, Milton RC, Seddon JM; Age-Related Eye Disease Study Research Group. Potential public health impact of Age-Related Eye Disease Study results: AREDS report no. 11. Arch Ophthalmol. 2003 Nov;121(11):1621-4. doi: 10.1001/archopht.121.11.1621.

  PMID: 14609922 BACKGROUND

• Lindblad AS, Clemons TE. Responsiveness of the National Eye Institute Visual Function Questionnaire to progression to advanced age-related macular degeneration, vision loss, and lens opacity: AREDS Report no. 14. Arch Ophthalmol. 2005 Sep;123(9):1207-14. doi: 10.1001/archopht.123.9.1207.

  PMID: 16157800 BACKGROUND

• Rankin MW, Clemons TE, McBee WL. Correlation analysis of the in-clinic and telephone batteries from the AREDS cognitive function ancillary study. AREDS Report No. 15. Ophthalmic Epidemiol. 2005 Aug;12(4):271-7. doi: 10.1080/09286580591003815.

  PMID: 16033748 BACKGROUND

• Davis MD, Gangnon RE, Lee LY, Hubbard LD, Klein BE, Klein R, Ferris FL, Bressler SB, Milton RC; Age-Related Eye Disease Study Group. The Age-Related Eye Disease Study severity scale for age-related macular degeneration: AREDS Report No. 17. Arch Ophthalmol. 2005 Nov;123(11):1484-98. doi: 10.1001/archopht.123.11.1484.

  PMID: 16286610 BACKGROUND

• Ferris FL, Davis MD, Clemons TE, Lee LY, Chew EY, Lindblad AS, Milton RC, Bressler SB, Klein R; Age-Related Eye Disease Study (AREDS) Research Group. A simplified severity scale for age-related macular degeneration: AREDS Report No. 18. Arch Ophthalmol. 2005 Nov;123(11):1570-4. doi: 10.1001/archopht.123.11.1570.

  PMID: 16286620 BACKGROUND

• Sperduto RD, Ferris FL 3rd, Kurinij N. Do we have a nutritional treatment for age-related cataract or macular degeneration? Arch Ophthalmol. 1990 Oct;108(10):1403-5. doi: 10.1001/archopht.1990.01070120051026. No abstract available.

  PMID: 2222272 BACKGROUND

• Age-Related Eye Disease Study Research Group. The effect of five-year zinc supplementation on serum zinc, serum cholesterol and hematocrit in persons randomly assigned to treatment group in the age-related eye disease study: AREDS Report No. 7. J Nutr. 2002 Apr;132(4):697-702. doi: 10.1093/jn/132.4.697.

  PMID: 11925463 RESULT

• Age-Related Eye Disease Study Research Group. Risk factors associated with age-related nuclear and cortical cataract : a case-control study in the Age-Related Eye Disease Study, AREDS Report No. 5. Ophthalmology. 2001 Aug;108(8):1400-8. doi: 10.1016/s0161-6420(01)00626-1.

  PMID: 11470690 RESULT

• Age-Related Eye Disease Study Research Group. Risk factors associated with age-related macular degeneration. A case-control study in the age-related eye disease study: Age-Related Eye Disease Study Report Number 3. Ophthalmology. 2000 Dec;107(12):2224-32. doi: 10.1016/s0161-6420(00)00409-7.

  PMID: 11097601 RESULT

• Age-Related Eye Disease Study Research Group. The Age-Related Eye Disease Study: a clinical trial of zinc and antioxidants--Age-Related Eye Disease Study Report No. 2. J Nutr. 2000 May;130(5S Suppl):1516S-9S. doi: 10.1093/jn/130.5.1516S.

  PMID: 10801969 RESULT

• Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E and beta carotene for age-related cataract and vision loss: AREDS report no. 9. Arch Ophthalmol. 2001 Oct;119(10):1439-52. doi: 10.1001/archopht.119.10.1439.

  PMID: 11594943 RESULT

• Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report no. 8. Arch Ophthalmol. 2001 Oct;119(10):1417-36. doi: 10.1001/archopht.119.10.1417.

  PMID: 11594942 RESULT

• Yaffe K, Clemons TE, McBee WL, Lindblad AS; Age-Related Eye Disease Study Research Group. Impact of antioxidants, zinc, and copper on cognition in the elderly: a randomized, controlled trial. Neurology. 2004 Nov 9;63(9):1705-7. doi: 10.1212/01.wnl.0000142969.19465.8f.

  PMID: 15534261 RESULT

• Clemons TE, Kurinij N, Sperduto RD; AREDS Research Group. Associations of mortality with ocular disorders and an intervention of high-dose antioxidants and zinc in the Age-Related Eye Disease Study: AREDS Report No. 13. Arch Ophthalmol. 2004 May;122(5):716-26. doi: 10.1001/archopht.122.5.716.

  PMID: 15136320 RESULT

• Clemons TE, Rankin MW, McBee WL; Age-Related Eye Disease Study Research Group. Cognitive impairment in the Age-Related Eye Disease Study: AREDS report no. 16. Arch Ophthalmol. 2006 Apr;124(4):537-43. doi: 10.1001/archopht.124.4.537.

  PMID: 16606880 RESULT

• Clemons TE, Milton RC, Klein R, Seddon JM, Ferris FL 3rd; Age-Related Eye Disease Study Research Group. Risk factors for the incidence of Advanced Age-Related Macular Degeneration in the Age-Related Eye Disease Study (AREDS) AREDS report no. 19. Ophthalmology. 2005 Apr;112(4):533-9. doi: 10.1016/j.ophtha.2004.10.047.

  PMID: 15808240 RESULT

• SanGiovanni JP, Chew EY, Clemons TE, Davis MD, Ferris FL 3rd, Gensler GR, Kurinij N, Lindblad AS, Milton RC, Seddon JM, Sperduto RD; Age-Related Eye Disease Study Research Group. The relationship of dietary lipid intake and age-related macular degeneration in a case-control study: AREDS Report No. 20. Arch Ophthalmol. 2007 May;125(5):671-9. doi: 10.1001/archopht.125.5.671.

  PMID: 17502507 RESULT

• Milton RC, Sperduto RD, Clemons TE, Ferris FL 3rd; Age-Related Eye Disease Study Research Group. Centrum use and progression of age-related cataract in the Age-Related Eye Disease Study: a propensity score approach. AREDS report No. 21. Ophthalmology. 2006 Aug;113(8):1264-70. doi: 10.1016/j.ophtha.2006.02.054.

  PMID: 16877067 RESULT

• Age-Related Eye Disease Study Research Group; SanGiovanni JP, Chew EY, Clemons TE, Ferris FL 3rd, Gensler G, Lindblad AS, Milton RC, Seddon JM, Sperduto RD. The relationship of dietary carotenoid and vitamin A, E, and C intake with age-related macular degeneration in a case-control study: AREDS Report No. 22. Arch Ophthalmol. 2007 Sep;125(9):1225-32. doi: 10.1001/archopht.125.9.1225.

  PMID: 17846363 RESULT

• SanGiovanni JP, Chew EY, Agron E, Clemons TE, Ferris FL 3rd, Gensler G, Lindblad AS, Milton RC, Seddon JM, Klein R, Sperduto RD; Age-Related Eye Disease Study Research Group. The relationship of dietary omega-3 long-chain polyunsaturated fatty acid intake with incident age-related macular degeneration: AREDS report no. 23. Arch Ophthalmol. 2008 Sep;126(9):1274-9. doi: 10.1001/archopht.126.9.1274.

  PMID: 18779490 RESULT

• Sperduto RD, Clemons TE, Lindblad AS, Ferris FL 3rd; Age-Related Eye Disease Study Research Group. Cataract classification using serial examinations in the age-related eye disease study: age-related eye disease study report no. 24. Am J Ophthalmol. 2008 Mar;145(3):504-8. doi: 10.1016/j.ajo.2007.10.024. Epub 2008 Jan 16.

  PMID: 18201681 RESULT

• Toulouie S, Chang S, Pan J, Snyder K, Yiu G. Relationship of Retinal Vessel Caliber with Age-Related Macular Degeneration. J Ophthalmol. 2022 Jul 31;2022:8210599. doi: 10.1155/2022/8210599. eCollection 2022.

  PMID: 35957743 DERIVED

• Snyder K, Yazdanyar A, Mahajan A, Yiu G. Association Between the Cilioretinal Artery and Choroidal Neovascularization in Age-Related Macular Degeneration: A Secondary Analysis From the Age-Related Eye Disease Study. JAMA Ophthalmol. 2018 Sep 1;136(9):1008-1014. doi: 10.1001/jamaophthalmol.2018.2650.

  PMID: 29978186 DERIVED

• Chiu CJ, Klein R, Milton RC, Gensler G, Taylor A. Does eating particular diets alter the risk of age-related macular degeneration in users of the Age-Related Eye Disease Study supplements? Br J Ophthalmol. 2009 Sep;93(9):1241-6. doi: 10.1136/bjo.2008.143412. Epub 2009 Jun 9.

  PMID: 19508997 DERIVED

MeSH Terms

Conditions

Macular Degeneration; Cataract

Interventions

Antioxidants; Zinc

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Emily Y. Chew, MD

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 23, 1999
• First Posted: September 24, 1999
• Study Start: September 1, 1990
• Primary Completion: October 1, 2001
• Study Completion: December 1, 2006
• Last Updated: January 23, 2009

Record last verified: 2009-01