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NCT00006202 · ClinicalTrials.gov registry record · Phase 2
Lutein for Age-Related Macular Degeneration
A Phase 2 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT00006202: Completed Phase 2 study, sponsored by National Eye Institute (NEI).
NCT00006202 is a Phase 2 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00006202, a Phase 2 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
This study will examine whether taking the vitamin lutein changes lutein blood levels. Lutein, vitamin C, vitamin E and beta-carotene may be useful in treating the eye disease age-related macular degeneration, but more information is needed to support this. Age-related macular degeneration can significantly impair the ability to read, drive, and carry out daily activities. It is the most common cause of vision loss in people over age 60. Lutein a carotenoid that occurs naturally in the retina (the back part of the eye), especially the macula-the part of the retina that is important for fine, detailed vision. Men and women 60 years of age and older, with or without age-related macular degeneration, may be eligible for this study. Candidates will undergo the following tests: 1. Medical history and physical examination. 2. Eye examination-Includes evaluation of visual acuity, measurement of eye pressure, examination of the lens, retina, pupils and eye movements, and photographs of the eye. 3. Visual field study-Examines the ability to see objects in the periphery. The subject looks at a target on a screen and indicates when lights that appear in other places on the screen are visible. 4. Flicker photometry-The subject looks at a flashing light and turns a knob until the light stops flashing. 5. Blood tests-To measure blood levels of lutein and other carotenoids, liver function, cholesterol and triglycerides. Participants will be randomly assigned to take one of three dosages of lutein (2.5 milligrams, 5 milligrams or 10 milligrams) for 6 months and will be examined at follow-up visits scheduled 1, 3, 6, 9 and 12 months after starting lutein. During these visits, many of the exams described above will be repeated to evaluate the effects of lutein treatment on the eye.
Interventions
- DRUG Lutein
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2000-09 |
| Est. Completion | 2003-08 |
| Phase | Phase 2 |
What the finished NCT00006202 record still lists
NCT00006202 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 1 intervention - of which Lutein is the first listed.
NCT00006202 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00006202 about?
NCT00006202 is a clinical study titled "Lutein for Age-Related Macular Degeneration". This study will examine whether taking the vitamin lutein changes lutein blood levels. Lutein, vitamin C, vitamin E and beta-carotene may be useful in treating the eye disease age-related macular degeneration, but more information is needed to support this. Age-related macular degeneration can signi...
What is the current status of trial NCT00006202?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2000-09. Estimated completion is 2003-08.
What interventions are being tested in trial NCT00006202?
The interventions under investigation include: Lutein (DRUG).
Who is sponsoring clinical trial NCT00006202?
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 NCT00006202's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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