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NCT00345176 · ClinicalTrials.gov registry record · Phase 3
Age-Related Eye Disease Study 2 (AREDS2)
A Phase 3 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 3
- Development phase
- 4,203
- Enrollment target
NCT00345176: Completed Phase 3 study, sponsored by National Eye Institute (NEI).
NCT00345176 is a Phase 3 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 4,203 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (444% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00345176, a Phase 3 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,203 participants
- Enrollment target
Study Summary
Oral supplementation with the Age-Related Eye Disease Study (AREDS) formulation (antioxidant vitamins C and E, beta carotene, and zinc) has been shown to reduce the risk of progression to advanced age-related macular degeneration (AMD). Observational data suggest that increased dietary intake of lutein + zeaxanthin (carotenoids), omega-3 long-chain polyunsaturated fatty acids (docosahexaenoic acid \[DHA\] + eicosapentaenoic acid \[EPA\]), or both might further reduce this risk. AREDS2 was designed to test whether adding lutein + zeaxanthin, DHA + EPA, or lutein + zeaxanthin and DHA + EPA to the AREDS formulation might further reduce the risk of progression to advanced AMD. A secondary goal was to test the effects of eliminating beta carotene and reducing zinc dose in the AREDS formulation.
Primary Outcome
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.
Interventions
- DIETARY_SUPPLEMENT Lutein/zeaxanthin
- DIETARY_SUPPLEMENT DHA/EPA
- DRUG Lutein/zeaxanthin and DHA/EPA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,203 participants |
| Start Date | 2006-09 |
| Est. Completion | 2012-10 |
| Phase | Phase 3 |
What the finished NCT00345176 record still lists
NCT00345176 is an interventional study that assigns participants to a tested intervention. Its 4,203 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (444% higher).
The record links to 0 conditions, and to 3 interventions - of which Lutein/zeaxanthin is the first listed.
NCT00345176 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00345176 about?
NCT00345176 is a clinical study titled "Age-Related Eye Disease Study 2 (AREDS2)". Oral supplementation with the Age-Related Eye Disease Study (AREDS) formulation (antioxidant vitamins C and E, beta carotene, and zinc) has been shown to reduce the risk of progression to advanced age-related macular degeneration (AMD). Observational data suggest that increased dietary intake of lut...
What is the current status of trial NCT00345176?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,203 participants. The study started on 2006-09. Estimated completion is 2012-10.
What interventions are being tested in trial NCT00345176?
The interventions under investigation include: Lutein/zeaxanthin (DIETARY_SUPPLEMENT), DHA/EPA (DIETARY_SUPPLEMENT), Lutein/zeaxanthin and DHA/EPA (DRUG).
Who is sponsoring clinical trial NCT00345176?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00345176's enrollment target sits among peer trials
4,203 59th of 2000 higher than 1,942 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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