Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006202
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-09-09
Brief Title:
Lutein for Age-Related Macular Degeneration
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Dose Ranging Study of Lutein Supplementation in Persons Over Age 60
Status:
COMPLETED
Status Verified Date:
2003-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 25 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
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 25 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
Detailed Description:
The primary objective of this study is to evaluate the association of varying doses of oral supplementation of lutein with the resulting serum levels of lutein in people over age 60 who may or may not have AMD Secondary objectives are to investigate the relationship between level of disease and lutein absorption and to assess change in macular pigment Assessment of macular pigment is not routinely performed in this patient population Including this assessment in the current study will further attempts to standardize its implementation If results appear to warrant further study a placebo-controlled study may be appropriate Patients will range from those with no AMD and little or no drusen in either eye through end stage AMD geographic atrophic retinal pigment epithelial detachment or other signs of neovascularexudative disease in the eye with worst disease AMD severity will be classified using Age-Related Eye Disease Study criteria for the definition of advanced AMD Appendix 2 Development of a safety profile is not a specific objective of this study To this point in time the available published data have not indicated any safety concerns However due to the lack of complete knowledge of potential toxicities safety assessments will be performed at all scheduled study visits These safety assessments include visual acuity complete ophthalmic examination fundus photos liver function tests visual field tests and a side-effect questionnaire from the AREDS Should safety concerns arise adverse event rates can be compared to the AREDS which is based on the same study population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-EI-0208 | None | None | None |