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

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ClinicalTrials.gov Identifier: NCT00784225
Recruitment Status : Active, not recruiting
First Posted : November 3, 2008
Last Update Posted : February 1, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Eye Institute (NEI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

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 or disease Intervention/treatment Phase
Cataract Macular Degeneration Drug: selenium Drug: vitamin E Drug: vitamin E placebo Drug: selenium placebo Phase 3

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]).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2774 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (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)
Study Start Date : July 2004
Primary Completion Date : November 2017
Estimated Study Completion Date : May 2018


Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  1. Advanced AMD [ Time Frame: Every 6 months ]
  2. Cataract extraction [ Time Frame: Every 6 months ]


Information from the National Library of Medicine

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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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 )
First Posted: November 3, 2008    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

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