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

This study is currently recruiting participants.
Verified December 2013 by Southwest Oncology Group
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00784225
First received: October 31, 2008
Last updated: December 2, 2013
Last verified: December 2013

October 31, 2008
December 2, 2013
July 2004
July 2015   (final data collection date for primary outcome measure)
  • Visually significant age-related macular degeneration (AMD) [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
  • Cataract with best corrected visual-acuity of 20/30 [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
  • Visually significant age-related macular degeneration (AMD) [ Designated as safety issue: No ]
  • Visually significant cataract [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00784225 on ClinicalTrials.gov Archive Site
  • Advanced AMD [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
  • Cataract extraction [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
  • Advanced AMD (evidence of geographic atrophy or exudative disease) [ Designated as safety issue: No ]
  • Total AMD (with or without vision loss) [ Designated as safety issue: No ]
  • Surgical removal of an incident cataract or subtype [ Designated as safety issue: No ]
Not Provided
Not Provided
 
S0000B: Vitamin E and/or Selenium in Preventing Cataract and Age-Related Macular Degeneration in Men on SELECT SWOG-S0000
S0000B: Prevention of Cataract and Age-Related Macular Degeneration With Vitamin E and Selenium - SELECT Eye Endpoints (SEE)

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).

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]).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Cataract
  • Macular Degeneration
  • 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
  • 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 placebo
    vitamin E and selenium placebo daily for 7-12 years
    Interventions:
    • Drug: vitamin E
    • Drug: selenium placebo
  • Experimental: Selenium + vitamin E placebo
    selenium and vitamin E placebo daily for 7-12 years
    Interventions:
    • Drug: selenium
    • Drug: vitamin E placebo
    • Drug: selenium placebo
  • Experimental: Vitamin E + selenium
    vitamin E and selenium placebo daily for 7-12 years
    Interventions:
    • Drug: selenium
    • Drug: vitamin E
  • Placebo Comparator: Vitamin E placebo + selenium placebo
    vitamin E placebo and selenium placebo daily for 7-12 years
    Interventions:
    • Drug: vitamin E placebo
    • Drug: selenium placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2970
October 2015
July 2015   (final data collection date for primary outcome measure)

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
Male
50 Years and older
Yes
Contact: Dana Sparks, MAT 210-614-8808 ext 1004
United States
 
NCT00784225
CDR0000617778, S0000B, U10CA037429, R01EY014418
Yes
Southwest Oncology Group
Southwest Oncology Group
  • National Cancer Institute (NCI)
  • National Eye Institute (NEI)
Study Chair: William Christen, ScD Dana-Farber/Brigham and Women's Cancer Center
Southwest Oncology Group
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP