S0000B: Vitamin E and/or Selenium in Preventing Cataract and Age-Related Macular Degeneration in Men on SELECT SWOG-S0000 - Full Text View

Purpose

RATIONALE: Aging may affect a person's vision. Vitamin E and/or selenium may help prevent cataracts or age-related macular degeneration in men receiving these drugs as part of a clinical trial for the prevention of prostate cancer.

PURPOSE: This clinical trial is studying vitamin E and/or selenium to see how well they work in preventing cataract and age-related macular degeneration in men enrolled on SELECT (SWOG-S0000).

Condition	Intervention	Phase
Cataract Macular Degeneration	Drug: selenium Drug: vitamin E Drug: vitamin E placebo Drug: selenium placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	S0000B: Prevention of Cataract and Age-Related Macular Degeneration With Vitamin E and Selenium - SELECT Eye Endpoints (SEE)

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration

MedlinePlus related topics: Cataract Macular Degeneration Vitamin E

Drug Information available for: alpha-Tocopherol Tocopherol Selenomethionine alpha-Tocopherol succinate Tocopherol acetate DL-alpha-Tocopherol

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:

Visually significant age-related macular degeneration (AMD) [ Time Frame: Every 6 months ]
Cataract with best corrected visual-acuity of 20/30 [ Time Frame: Every 6 months ]

Secondary Outcome Measures:

Advanced AMD [ Time Frame: Every 6 months ]
Cataract extraction [ Time Frame: Every 6 months ]


Estimated Enrollment:	2970
Study Start Date:	July 2004
Estimated Study Completion Date:	June 2017
Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vitamin E + selenium placebo vitamin E and selenium placebo daily for 7-12 years	Drug: vitamin E 400 IU daily by mouth for 7-12 years Other Name: alpha tocopherol Drug: selenium placebo daily for 7-12 years Other Name: placebo
Experimental: Selenium + vitamin E placebo selenium and vitamin E placebo daily for 7-12 years	Drug: selenium 200 mcg daily for 7-12 years Other Name: L-selenomethionine Drug: vitamin E placebo daily for 7-12 years Other Name: placebo Drug: selenium placebo daily for 7-12 years Other Name: placebo
Experimental: Vitamin E + selenium vitamin E and selenium placebo daily for 7-12 years	Drug: selenium 200 mcg daily for 7-12 years Other Name: L-selenomethionine Drug: vitamin E 400 IU daily by mouth for 7-12 years Other Name: alpha tocopherol
Placebo Comparator: Vitamin E placebo + selenium placebo vitamin E placebo and selenium placebo daily for 7-12 years	Drug: vitamin E placebo daily for 7-12 years Other Name: placebo Drug: selenium placebo daily for 7-12 years Other Name: placebo

Detailed Description:

OBJECTIVES:

Primary

To test whether vitamin E and/or selenium reduces the risk of visually significant age-related macular degeneration (AMD) in men enrolled on SELECT (SWOG-S0000).
To test whether vitamin E and/or selenium reduces the risk of cataract in these participants.

Secondary

To test whether vitamin E and/or selenium reduces the risk of advanced AMD in these participants.
To test whether vitamin E and/or selenium reduces the risk of cataract surgery and subtypes in these participants.

OUTLINE: This is a multicenter study.

Data from medical records obtained from the participant's ophthalmologist or optometrist are reviewed. Information from these records is then used to confirm baseline reports of age-related macular degeneration (AMD) as well as 6-month and annual reports of new diagnoses of AMD and cataract (or cataract surgery) made since the start of this study. Detailed questionnaires are also obtained from the participant's ophthalmologist or optometrist to provide information about the reported AMD or cataract diagnosis (e.g., date of initial diagnosis; best-corrected visual acuity at the time of diagnosis; date when visual acuity was first noted to be 20/30 or worse [if different from the date of initial diagnosis]; pathological findings observed when AMD was first diagnosed [e.g., drusen, retinal pigment epithelial hypo/hyperpigmentation, geographic atrophy, retinal pigment epithelial detachment, subretinal neovascular membrane, or disciform scar]; pathological findings observed when visual acuity was first noted to be 20/30 or worse; date when exudative [wet] AMD was first noted; presence of other ocular abnormalities that could explain or contribute to visual loss; whether AMD or cataract, by itself, are significant enough to cause vision to be reduced to 20/30 or worse; whether laser treatment or photodynamic therapy was performed for AMD; date of cataract extraction; etiology of cataract [e.g., age-related, traumatic, congenital, inflammatory, or surgery- or steroid-induced]; and cataract type [e.g., nuclear, cortical, posterior subcapsular, or other]).

Eligibility


Ages Eligible for Study:	50 Years to 120 Years (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Enrolled on the Selenium and Vitamin E Prostate Cancer Prevention Trial (SELECT) SWOG-S0000
Diagnosis of 1 of the following:
- Age-related macular degeneration (AMD) at baseline or at follow-up
- Cataract or a cataract extraction at follow-up (Closed for accrual as of 10/01/29)
  - Participants with a prior diagnosis of cataract at baseline followed by another cataract event (cataract diagnosis or a cataract extraction) at follow-up are not eligible
  - Participants with a prior diagnosis of cataract at baseline followed by a diagnosis of AMD at follow-up are eligible

PATIENT CHARACTERISTICS:

See Disease Characteristics

PRIOR CONCURRENT THERAPY:

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784225

Locations


United States, Massachusetts
Harvard Medical School
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

National Eye Institute (NEI)

Investigators


Study Chair:	William Christen, ScD	Dana-Farber/Brigham and Women's Cancer Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Goodman PJ, Tangen CM, Darke AK, Arnold KB, Hartline J, Yee M, Anderson K, Caban-Holt A, Christen WG, Cassano PA, Lance P, Klein EA, Crowley JJ, Minasian LM, Meyskens FL. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial. Trials. 2016 Aug 12;17:400. doi: 10.1186/s13063-016-1524-9.

Christen WG, Glynn RJ, Gaziano JM, Darke AK, Crowley JJ, Goodman PJ, Lippman SM, Lad TE, Bearden JD, Goodman GE, Minasian LM, Thompson IM Jr, Blanke CD, Klein EA. Age-related cataract in men in the selenium and vitamin e cancer prevention trial eye endpoints study: a randomized clinical trial. JAMA Ophthalmol. 2015 Jan;133(1):17-24. doi: 10.1001/jamaophthalmol.2014.3478.


Responsible Party:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT00784225 History of Changes
Other Study ID Numbers:	CDR0000617778 S0000B ( Other Identifier: SWOG ) U10CA037429 ( U.S. NIH Grant/Contract ) R01EY014418 ( U.S. NIH Grant/Contract )
Study First Received:	October 31, 2008
Last Updated:	December 21, 2016

Keywords provided by Southwest Oncology Group:


cataract advanced macular degeneration

Additional relevant MeSH terms:


Macular Degeneration Cataract Retinal Degeneration Retinal Diseases Eye Diseases Lens Diseases Vitamins Vitamin E Tocopherols Tocotrienols	alpha-Tocopherol Selenium Micronutrients Growth Substances Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Trace Elements

ClinicalTrials.gov processed this record on July 17, 2017

S0000B: Vitamin E and/or Selenium in Preventing Cataract and Age-Related Macular Degeneration in Men on SELECT SWOG-S0000 (SEE)