Macular DegenerationPhase 3NCT00000145
Age-Related Eye Disease Study (AREDS)
A Phase 3 study testing Antioxidants, Zinc and Antioxidants and zinc in people with Macular Degeneration and Cataract, run by National Eye Institute (NEI).
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Macular Degeneration, Cataract, Lens Opacities
- What is being tested?
- Antioxidants, Zinc and Antioxidants and zinc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,757 participants
- Where
- No sites listed yet
- Study dates
- Sep 1990to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
About this study
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.
Read the detailed description
AMD and cataract are the leading causes of visual impairment and blindness in the United States. Based on many clinical studies, it is apparent that the frequency of both diseases increases dramatically after age 60. Although excellent treatments for cataract are available, there are no equivalent treatments for AMD. As the average lifespan of our population increases, the number of people who develop AMD will increase dramatically in the years ahead. Unless successful means of prevention or treatment are developed, blindness from AMD -- and its importance as a public health problem -- will increase.
Neither the etiology nor the natural history of AMD or cataract is known. Epidemiologic studies suggest that a number of risk factors may be associated with AMD and cataract, but the strength of the evidence in support of these hypotheses varies. Possibly associated with AMD are personal characteristics, such as age, race, height, family history, and strength of hand grip; ocular characteristics, such as hyperopia and color of iris; and cardiovascular diseases, smoking, lung infections, and chemical exposures. Clinical and laboratory studies suggest the following factors may be associated with progression of AMD: drusen type, choroidal vascular diseases, and photic injury.
Epidemiologic studies of cataract suggest that associated risk factors may include personal characteristics, such as age, sex, race, occupation, and educational status; ocular characteristics, such as iris color; and diabetes mellitus, hypertension, drug exposure, smoking, and sunlight exposure. Animal studies and observational epidemiologic studies suggest that deficiencies in vitamins C and E, carotenoids, and the trace elements zinc and selenium also may be associated with the development of the two diseases, especially cataract. Although surgical treatment to remove cataract is very effective, cataract surgery carries risks, as does any other surgery. Therefore, many research efforts focus on preventing or slowing cataract development, as well as on determining the causes of cataract formation.
The Age-Related Eye Disease Study (AREDS) is a major research program to improve our understanding of the predisposing factors, clinical course, and prognostic factors of AMD and cataract. Eligible patients are randomized to treatment with placebo, antioxidants, zinc, or antioxidants plus zinc, and are followed for a minimum of 5 years.
- Conditions
- Macular Degeneration, Cataract, Lens Opacities
- Being tested
- Antioxidants, Zinc, Antioxidants and zinc
- Keywords
- Age-Related Macular Degeneration
- Medical subject headings
- Macular Degeneration, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntioxidantsDietary supplement
500 milligrams vitamin C; 400 IUs vitamin E; 15 milligrams beta-carotene
ZincDietary supplement
80 milligrams zinc oxide; 2 milligrams of cupric oxide
Antioxidants and zincDietary supplement
500 milligrams vitamin C; 400 IUs vitamin E; 15 milligrams beta-carotene; 80 milligrams zinc oxide; 2 milligrams of cupric oxide
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Antioxidants Receives: Dietary Supplement: Antioxidants |
| 2 | Experimental | Zinc Receives: Dietary Supplement: Zinc |
| 3 | Experimental | Antioxidants and zinc Receives: Dietary Supplement: Antioxidants and zinc |
| 4 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of age-related macular degeneration
Progression of lens opacity (cataract)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 1999 (estimated)
- Study startSep 1990
- Primary completionOct 2001
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,757 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Bausch & Lomb Incorporated
- Investigators
- Emily Y. Chew, MD, Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000145
- Sponsor's protocol ID
- NEI-44
- Status last verified
- Jan 2009
- First submitted
- 23 Sep 1999
- Last updated
- 23 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11704028Age-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.
PubMed 11228291Age-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.
PubMed 10588299Clemons 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.
PubMed 12583787Bressler 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.
PubMed 14609922Lindblad 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.
PubMed 16157800Rankin 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.
PubMed 16033748Davis 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.
PubMed 16286610Ferris 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.
PubMed 16286620Sperduto 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.
PubMed 2222272Age-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.
PubMed 11925463Age-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.
PubMed 11470690Age-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.
PubMed 11097601Age-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.
PubMed 10801969Age-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.
PubMed 11594943
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-Related Eye Disease Study (AREDS)
- ClinicalTrials.gov ID
- NCT00000145
- Acronym / sponsor ID
- NEI-44
- Conditions
- Macular Degeneration, Cataract, Lens Opacities
- Keywords
- Age-Related Macular Degeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,757 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- Sep 1990
- Primary completion
- Oct 2001 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 24 Sep 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
AMD and cataract are the leading causes of visual impairment and blindness in the United States. Based on many clinical studies, it is apparent that the frequency of both diseases increases dramatically after age 60. Although excellent treatments for cataract are available, there are no equivalent treatments for AMD. As the average lifespan of our population increases, the number of people who develop AMD will increase dramatically in the years ahead. Unless successful means of prevention or treatment are developed, blindness from AMD -- and its importance as a public health problem -- will increase.
Neither the etiology nor the natural history of AMD or cataract is known. Epidemiologic studies suggest that a number of risk factors may be associated with AMD and cataract, but the strength of the evidence in support of these hypotheses varies. Possibly associated with AMD are personal characteristics, such as age, race, height, family history, and strength of hand grip; ocular characteristics, such as hyperopia and color of iris; and cardiovascular diseases, smoking, lung infections, and chemical exposures. Clinical and laboratory studies suggest the following factors may be associated with progression of AMD: drusen type, choroidal vascular diseases, and photic injury.
Epidemiologic studies of cataract suggest that associated risk factors may include personal characteristics, such as age, sex, race, occupation, and educational status; ocular characteristics, such as iris color; and diabetes mellitus, hypertension, drug exposure, smoking, and sunlight exposure. Animal studies and observational epidemiologic studies suggest that deficiencies in vitamins C and E, carotenoids, and the trace elements zinc and selenium also may be associated with the development of the two diseases, especially cataract. Although surgical treatment to remove cataract is very effective, cataract surgery carries risks, as does any other surgery. Therefore, many research efforts focus on preventing or slowing cataract development, as well as on determining the causes of cataract formation.
The Age-Related Eye Disease Study (AREDS) is a major research program to improve our understanding of the predisposing factors, clinical course, and prognostic factors of AMD and cataract. Eligible patients are randomized to treatment with placebo, antioxidants, zinc, or antioxidants plus zinc, and are followed for a minimum of 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: AntioxidantsAntioxidants |
| 2 | Experimental | Dietary Supplement: ZincZinc |
| 3 | Experimental | Dietary Supplement: Antioxidants and zincAntioxidants and zinc |
| 4 | No intervention | – |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antioxidants500 milligrams vitamin C; 400 IUs vitamin E; 15 milligrams beta-carotene | Dietary supplement | 1 |
| Zinc80 milligrams zinc oxide; 2 milligrams of cupric oxide | Dietary supplement | 2 |
| Antioxidants and zinc500 milligrams vitamin C; 400 IUs vitamin E; 15 milligrams beta-carotene; 80 milligrams zinc oxide; 2 milligrams of cupric oxide | Dietary supplement | 3 |
Primary outcome
Progression of age-related macular degeneration
Progression of lens opacity (cataract)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2009.
- Background: PubMed 11704028Age-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.
- Background: PubMed 11228291Age-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.
- Background: PubMed 10588299Age-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.
- Background: PubMed 12583787Clemons 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.
- Background: PubMed 14609922Bressler 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.
- Background: PubMed 16157800Lindblad 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.
- Background: PubMed 16033748Rankin 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.
- Background: PubMed 16286610Davis 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.
- Background: PubMed 16286620Ferris 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.
- Background: PubMed 2222272Sperduto 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.
- Results publication: PubMed 11925463Age-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.
- Results publication: PubMed 11470690Age-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.
Related trials for Macular Degeneration
RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease
Active, not recruitingPhase 4
A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration
Geographic Atrophy, Age-Related Macular Degeneration
RecruitingObservational study
Age-Related Macular Degeneration Benchmark Imaging Dataset (ABID)
Age-Related Macular Degeneration
Active, not recruitingPhase 1/2
Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy
Geographic Atrophy
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Y. Chew, MD principal investigator
National Eye Institute (NEI)
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antioxidants, Zinc and Antioxidants and zinc in people with Macular Degeneration and Cataract, run by National Eye Institute (NEI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of age-related macular degeneration. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000145, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2009.