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

Phase 3

Completed

Conditions: Macular Degeneration
Cataract

Interventions: Drug: vitamin E
Drug: vitamin E placebo
Drug: selenium
Drug: selenium placebo

Registration Number: NCT00784225

Lead Sponsor: SWOG Cancer Research Network

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

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 13475

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Vitamin E placebo + selenium placebo	selenium placebo	vitamin E placebo and selenium placebo daily for 7-12 years
Vitamin E + selenium placebo	vitamin E	vitamin E and selenium placebo daily for 7-12 years
Vitamin E placebo + selenium placebo	vitamin E placebo	vitamin E placebo and selenium placebo daily for 7-12 years
Selenium + vitamin E placebo	vitamin E placebo	selenium and vitamin E placebo daily for 7-12 years
Vitamin E + selenium	selenium	vitamin E and selenium placebo daily for 7-12 years
Vitamin E + selenium placebo	selenium placebo	vitamin E and selenium placebo daily for 7-12 years
Selenium + vitamin E placebo	selenium placebo	selenium and vitamin E placebo daily for 7-12 years
Selenium + vitamin E placebo	selenium	selenium and vitamin E placebo daily for 7-12 years
Vitamin E + selenium	vitamin E	vitamin E and selenium placebo daily for 7-12 years

Primary Outcome Measures

Name	Time	Method
Number of Participants With Cataract and Best Corrected Visual-acuity of 20/30	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.
Number of Participants With Visually Significant Age-related Macular Degeneration (AMD)	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)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Advanced AMD	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	Every 6 months, up to 7 years	Cataract extraction was defined as the surgical removal of an incident cataract.