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

Study Overview
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Brief Summary
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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
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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]).

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

Conditions
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Cataract, Macular Degeneration

Intervention / Treatment
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* Drug: selenium
* Drug: vitamin E
* Drug: vitamin E placebo
* Drug: selenium placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin E + selenium placebo<br>vitamin E and selenium placebo daily for 7-12 years | Drug: vitamin E<br>* 400 IU daily by mouth for 7-12 years<br>* Other names: alpha tocopherol;Drug: selenium placebo<br>* daily for 7-12 years<br>* Other names: placebo;|
| Experimental: Selenium + vitamin E placebo<br>selenium and vitamin E placebo daily for 7-12 years | Drug: selenium<br>* 200 mcg daily for 7-12 years<br>* Other names: L-selenomethionine;Drug: vitamin E placebo<br>* daily for 7-12 years<br>* Other names: placebo;Drug: selenium placebo<br>* daily for 7-12 years<br>* Other names: placebo;|
| Experimental: Vitamin E + selenium<br>vitamin E and selenium placebo daily for 7-12 years | Drug: selenium<br>* 200 mcg daily for 7-12 years<br>* Other names: L-selenomethionine;Drug: vitamin E<br>* 400 IU daily by mouth for 7-12 years<br>* Other names: alpha tocopherol;|
| Placebo Comparator: Vitamin E placebo + selenium placebo<br>vitamin E placebo and selenium placebo daily for 7-12 years | Drug: vitamin E placebo<br>* daily for 7-12 years<br>* Other names: placebo;Drug: selenium placebo<br>* daily for 7-12 years<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Visually Significant Age-related Macular Degeneration (AMD) | 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) | Every 6 months, up to 7 years | 
| Number of Participants With Cataract and Best Corrected Visual-acuity of 20/30 | 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. | Every 6 months, up to 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Advanced AMD | 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. | Every 6 months, up to 7 years | 
| Number of Participants Who Underwent Cataract Extraction | Cataract extraction was defined as the surgical removal of an incident cataract. | Every 6 months, up to 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract, advanced macular degeneration