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

Overview

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 Title of Study: “S0000B: Prevention of Cataract and Age-Related Macular Degeneration With Vitamin E and Selenium – SELECT Eye Endpoints (SEE)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2017

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]).

Interventions

  • Drug: selenium
    • 200 mcg daily for 7-12 years
  • Drug: vitamin E
    • 400 IU daily by mouth for 7-12 years
  • Drug: vitamin E placebo
    • daily for 7-12 years
  • Drug: selenium placebo
    • daily for 7-12 years

Arms, Groups and Cohorts

  • Experimental: Vitamin E + selenium placebo
    • vitamin E and selenium placebo daily for 7-12 years
  • Experimental: Selenium + vitamin E placebo
    • selenium and vitamin E placebo daily for 7-12 years
  • Experimental: Vitamin E + selenium
    • vitamin E and selenium placebo daily for 7-12 years
  • Placebo Comparator: Vitamin E placebo + selenium placebo
    • vitamin E placebo and selenium placebo daily for 7-12 years

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Visually Significant Age-related Macular Degeneration (AMD)
    • Time Frame: Every 6 months, up to 7 years
    • Visually significant age-related AMD was defined as incident AMD responsible for reduction in best corrected visual acuity to 20/30 or worse(AMD 20/30)
  • Number of Participants With Cataract and Best Corrected Visual-acuity of 20/30
    • Time Frame: Every 6 months, up to 7 years
    • Incident cataract was defined as lens opacity diagnosed after randomization but prior to end of study, age-related in origin, and best-corrected visual acuity of 20/30 or worse attributable to the opacity.

Secondary Measures

  • Number of Participants With Advanced AMD
    • Time Frame: Every 6 months, up to 7 years
    • Advanced AMD was defined as the occurrence of disciform scars, or geographic atrophy or retinal pigment epithelium (RPE) detachment in either or both eyes at AMD diagnosis.
  • Number of Participants Who Underwent Cataract Extraction
    • Time Frame: Every 6 months, up to 7 years
    • Cataract extraction was defined as the surgical removal of an incident cataract.

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 50 Years

Maximum Age: 120 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Southwest Oncology Group
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • William Christen, ScD, Study Chair, Dana-Farber/Brigham and Women’s Cancer Center

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