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

SWOG Cancer Research Network

Status and phase: Completed; Phase 3

Conditions: Macular Degeneration; Cataract

Treatments: Drug: vitamin E; Drug: selenium placebo; Drug: vitamin E placebo; Drug: selenium

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00784225

S0000B (Other Identifier)

R01EY014418 (U.S. NIH Grant/Contract)

U10CA037429 (U.S. NIH Grant/Contract)

CDR0000617778

Details and patient eligibility

About

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).

Full 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]).

Enrollment: 13,475 patients

Sex: Male

Ages: 50 to 120 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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:

• Not applicable

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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13,475 participants in 4 patient groups, including a placebo group

Vitamin E + selenium placebo

Experimental group

Description:

vitamin E and selenium placebo daily for 7-12 years

Treatment:

Drug: selenium placebo

Drug: vitamin E

Selenium + vitamin E placebo

Experimental group

Description:

selenium and vitamin E placebo daily for 7-12 years

Treatment:

Drug: selenium

Drug: vitamin E placebo

Drug: selenium placebo

Vitamin E + selenium

Experimental group

Description:

vitamin E and selenium placebo daily for 7-12 years

Treatment:

Drug: selenium

Drug: vitamin E

Vitamin E placebo + selenium placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: vitamin E placebo

Drug: selenium placebo