- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006202
Lutein for Age-Related Macular Degeneration
Dose Ranging Study of Lutein Supplementation in Persons Over Age 60
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:
- Medical history and physical examination.
- 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.
- 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.
- Flicker photometry-The subject looks at a flashing light and turns a knob until the light stops flashing.
- 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.
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Eye Institute (NEI)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
Men and women aged 60 years or older.
Patients ranging from no AMD with little or no drusen in either eye through end stage AMD (geographic atrophic, retinal pigment epithelial detachment, or other signs of neovascular/exudative disease) in their eye with worst disease will be eligible.
The ability to understand and sign an informed consent form prior to enrollment.
EXCLUSION CRITERIA:
Ocular disease which confounds assessment of the retina other than age-related macular degeneration including diabetic retinopathy, central serous choroidopathy, optic atrophy, retinal vein occlusion, active uveitis, significant explained or unexplained visual field loss, or any other type of retinopathy or retinal degeneration.
Chronic requirement for any systemic or ocular medication for other diseases such as glaucoma.
Patients has regularly been taking lutein supplements during the last 3 months or is currently taking lutein supplements. The daily use of the new Centrum or Centrum Silver or other similar multivitamins will be allowed but should be limited to a maximum of twice a day.
Abnormal liver function tests.
Inability to be followed for a period of 1 year.
Acute potentially life-threatening illness such as heart attack in the last year, malignant cancer or blood disease not in remission.
History of lung cancer.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Seddon JM, Ajani UA, Sperduto RD, Hiller R, Blair N, Burton TC, Farber MD, Gragoudas ES, Haller J, Miller DT, et al. Dietary carotenoids, vitamins A, C, and E, and advanced age-related macular degeneration. Eye Disease Case-Control Study Group. JAMA. 1994 Nov 9;272(18):1413-20. Erratum In: JAMA 1995 Feb 22;273(8):622.
- Machemer R, Steinhorst UH. Retinal separation, retinotomy, and macular relocation: II. A surgical approach for age-related macular degeneration? Graefes Arch Clin Exp Ophthalmol. 1993 Nov;231(11):635-41. doi: 10.1007/BF00921957.
- de Juan E Jr, Loewenstein A, Bressler NM, Alexander J. Translocation of the retina for management of subfoveal choroidal neovascularization II: a preliminary report in humans. Am J Ophthalmol. 1998 May;125(5):635-46. doi: 10.1016/s0002-9394(98)00018-x.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000208
- 00-EI-0208
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Macular Degeneration
-
Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationChina
-
Hoffmann-La RocheWithdrawnNeovascular Age-Related Macular DegenerationDenmark, Argentina, Hong Kong, Thailand, Portugal, Greece, Spain
-
Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationSpain, Italy, Germany, Canada, Ireland
-
Novartis PharmaceuticalsTerminatedNeovascular Age-Related Macular Degeneration
-
Regeneron PharmaceuticalsCompletedNeovascular Age Related Macular DegenerationUnited States
-
Hoffmann-La RocheRecruitingNeovascular Age Related Macular Degeneration | nAMDChina
-
Centre Hospitalier Intercommunal CreteilCompletedMacular Degeneration Exudative Eye Left | Macular Degeneration Exudative Eye RightFrance
-
University of Modena and Reggio EmiliaCompletedMacular Degeneration Advanced | Macular Degeneration, Dry | Macular Degeneration, Senile | Macular Scar | Macular Degeneration NonexudativeItaly
-
Shanghai Refreshgene Technology Co., Ltd.RecruitingNeovascular Age-related Macular DegenerationChina
-
PharmAbcineC&R Research, Inc.RecruitingNeovascular Age-related Macular DegenerationKorea, Republic of
Clinical Trials on Lutein
-
Peking UniversityUnknownAge-related Macular DegenerationChina
-
Peking UniversityCompletedAge-related Macular DegenerationChina
-
Northcentral UniversityActive, not recruitingCognitive Change | Diet, Healthy | Eye FatigueUnited States
-
National Eye Institute (NEI)Completed
-
Chrysantis, Inc.Kowa Company, Ltd.; IMAGE TECHNOLOGIES INC.CompletedCognition Disorders | Age Related Macular DegenerationUnited States
-
University of GeorgiaDSM Nutritional Products, Inc.Completed
-
Wageningen UniversityCompleted
-
Johns Hopkins UniversityClark Charitable Foundation Inc.CompletedOcular Albinism (OA) | Oculocutaneous Albinism (OCA)United States
-
University of CopenhagenRigshospitalet, Denmark; Glostrup University Hospital, Copenhagen; Agroscope... and other collaboratorsTerminatedHealthy | Ileostomy; Functional DisturbanceDenmark
-
Federal University of São PauloCompletedProliferative Diabetic Retinopathy | Epiretinal Membrane | Macular HoleBrazil