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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

13475 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2018-05-31

Brief Summary

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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).

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Detailed Description

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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 \[e.g., nuclear, cortical, posterior subcapsular, or other\]).

Conditions

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Cataract Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin E + selenium placebo

vitamin E and selenium placebo daily for 7-12 years

Group Type EXPERIMENTAL

vitamin E

Intervention Type DRUG

400 IU daily by mouth for 7-12 years

selenium placebo

Intervention Type DRUG

daily for 7-12 years

Selenium + vitamin E placebo

selenium and vitamin E placebo daily for 7-12 years

Group Type EXPERIMENTAL

selenium

Intervention Type DRUG

200 mcg daily for 7-12 years

vitamin E placebo

Intervention Type DRUG

daily for 7-12 years

selenium placebo

Intervention Type DRUG

daily for 7-12 years

Vitamin E + selenium

vitamin E and selenium placebo daily for 7-12 years

Group Type EXPERIMENTAL

selenium

Intervention Type DRUG

200 mcg daily for 7-12 years

vitamin E

Intervention Type DRUG

400 IU daily by mouth for 7-12 years

Vitamin E placebo + selenium placebo

vitamin E placebo and selenium placebo daily for 7-12 years

Group Type PLACEBO_COMPARATOR

vitamin E placebo

Intervention Type DRUG

daily for 7-12 years

selenium placebo

Intervention Type DRUG

daily for 7-12 years

Interventions

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selenium

200 mcg daily for 7-12 years

Intervention Type DRUG

vitamin E

400 IU daily by mouth for 7-12 years

Intervention Type DRUG

vitamin E placebo

daily for 7-12 years

Intervention Type DRUG

selenium placebo

daily for 7-12 years

Intervention Type DRUG

Other Intervention Names

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L-selenomethionine alpha tocopherol placebo placebo

Eligibility Criteria

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Inclusion Criteria

* 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:

* Not applicable

Minimum Eligible Age

50 Years

Maximum Eligible Age

120 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes