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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 is a Phase 2 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 45 participants.

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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

FieldValue
Enrollment Target 45 participants
Start Date 2000-09
Est. Completion 2003-08
Phase Phase 2

Sponsor

National Eye Institute (NEI)

221 total trials

What the Registry Record Tells You About NCT00006202

The ClinicalTrials.gov registry entry for NCT00006202 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Lutein is the first listed.

NCT00006202 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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