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Completed

NCT Number: NCT00784225

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

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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Key information

Age range

50 year–120 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Harvard Medical School

Boston, Massachusetts, 02215, United States

About this study

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]).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

selenium

Drug

200 mcg daily for 7-12 years

Other names: L-selenomethionine

Vitamin E

Drug

400 IU daily by mouth for 7-12 years

Other names: alpha tocopherol

vitamin E placebo

Drug

daily for 7-12 years

Other names: placebo

selenium placebo

Drug

daily for 7-12 years

Other names: placebo

Primary outcomes

  1. 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)

  2. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

SWOG Cancer Research Network

Network

Collaborators

  • National Cancer Institute (NCI)
  • National Eye Institute (NEI)

Registry information

Official study title

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

Acronym: SEE

Important dates

Study start
2004
Primary completion
2017
Study completion
2018
First posted
Nov 3, 2008
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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