NCT00784225

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13,475 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: Male
• Age: 50 Years – 120 Years
• Healthy volunteers: Accepted

Summary

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).

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

Conditions

• Cataract
• Macular Degeneration

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-07-01
• Primary completion: 2017-11-01
• Completion: 2018-05-01
• First posted: 2008-11-03
• Last updated: 2019-08-14
• Results posted: 2019-07-23

Locations

1 site across 1 country: United States