Clinical trial NCT00784225: S0000B: Vitamin E and/or Selenium in Preventing Cataract and Age-Related Macular Degeneration in Men on SELECT SWOG-S0000
Official title: S0000B: Prevention of Cataract and Age-Related Macular Degeneration With Vitamin E and Selenium - SELECT Eye Endpoints (SEE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Macular Degeneration
Keywords: cataract
advanced macular degeneration
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: National Eye Institute (NEI)
First posted: 2008-11-02
Enrollment: 13475
Sex: MALE
Minimum age (years): 50
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Number of Participants With Visually Significant Age-related Macular Degeneration (AMD)
timeFrame: Every 6 months, up to 7 years
measure: Number of Participants With Cataract and Best Corrected Visual-acuity of 20/30
timeFrame: Every 6 months, up to 7 years
Secondary outcomes:
measure: Number of Participants With Advanced AMD
timeFrame: Every 6 months, up to 7 years
measure: Number of Participants Who Underwent Cataract Extraction
timeFrame: Every 6 months, up to 7 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard Medical School
state: Massachusetts
Study officials:
affiliation: Dana-Farber/Brigham and Women's Cancer Center
name: William Christen, ScD
role: STUDY_CHAIR
References:
citation: Goodman PJ, Tangen CM, Darke AK, Arnold KB, Hartline J, Yee M, Anderson K, Caban-Holt A, Christen WG, Cassano PA, Lance P, Klein EA, Crowley JJ, Minasian LM, Meyskens FL. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial. Trials. 2016 Aug 12;17:400. doi: 10.1186/s13063-016-1524-9.
citation: Christen WG, Glynn RJ, Gaziano JM, Darke AK, Crowley JJ, Goodman PJ, Lippman SM, Lad TE, Bearden JD, Goodman GE, Minasian LM, Thompson IM Jr, Blanke CD, Klein EA. Age-related cataract in men in the selenium and vitamin e cancer prevention trial eye endpoints study: a randomized clinical trial. JAMA Ophthalmol. 2015 Jan;133(1):17-24. doi: 10.1001/jamaophthalmol.2014.3478.