Phase 3
N=13,475
S0000B: Vitamin E and/or Selenium in Preventing Cataract and Age-Related Macular Degeneration in Men on SELECT SWOG-S0000
Cataract · Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT00784225 ↗Enrolled (actual)
13,475
Serious AEs
1.3%
Results posted
Jul 2019
Primary outcome: Primary: Number of Participants With Visually Significant Age-related Macular Degeneration (AMD) — 9; 12; 9; 12 Participants — p=0.52
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- selenium (Drug); vitamin E (Drug); vitamin E placebo (Drug); selenium placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Visually Significant Age-related Macular Degeneration (AMD) |
9; 12; 9; 12; 6681; 6687 | 0.52 |
| PRIMARY Number of Participants With Cataract and Best Corrected Visual-acuity of 20/30 |
185; 204; 197; 192; 5409; 5469 | 0.37 |
| SECONDARY Number of Participants With Advanced AMD |
10; 4; 7; 7; 6680; 6695 | 0.12 |
| SECONDARY Number of Participants Who Underwent Cataract Extraction |
99; 120; 114; 105; 5495; 5553 | 0.19 |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00784225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.