Conditions: Cataract Macular Degeneration
Keywords: cataract advanced macular degeneration
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 13475
Healthy volunteers: yes

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

Arms:
arm 1: vitamin E and selenium placebo daily for 7-12 years arm 2: selenium and vitamin E placebo daily for 7-12 years arm 3: vitamin E and selenium placebo daily for 7-12 years arm 4: vitamin E placebo and selenium placebo daily for 7-12 years

Interventions: intervention 1: selenium intervention 2: vitamin E intervention 3: vitamin E placebo intervention 4: selenium placebo
Intervention descriptions: intervention 1: 200 mcg daily for 7-12 years intervention 2: 400 IU daily by mouth for 7-12 years intervention 3: daily for 7-12 years intervention 4: daily for 7-12 years

Protocol document:
Prot_SAP_ICF_000.pdf: 
 
 
 
 
 
 
 
September 1, 2015 
 
 
TO: 
Principal Investigators and Head Clinical Research Associates at Participating Study 
Centers and Study Sites listed in Appendix 19.5 of the SELECT protocol 
 
 
FROM: 
Dana B. Sparks, M.A.T. - Protocol Product Line Manager 
 
 
RE: 
S0000B, "Prevention of Cataract and Age-Related Macular Degeneration with Vitamin E 
and Selenium – SELECT Eye Endpoints (SEE), Phase III Ancillary to S0000 - SELECT." 
Study Coordinators:  Drs. W. Christen, R.J. Glynn and J.M. Gaziano. 
 
STATUS NOTICE 
 
Study Coordinator:  William Christen, Sc.D. 
Phone number:  617/278-0795 
E-mail:  wchristen@rics.bwh.harvard.edu 
 
IRB Review Requirements 
 
(   ) 
Full board review required.  Reason: 
 
(   ) 
Initial activation (should your institution choose to participate) 
 
(   ) 
Increased risk to patient 
 
(   ) 
Complete study redesign 
 
(   ) 
Addition of tissue banking requirements 
 
(   ) 
Study closure due to new risk information 
 
(  ) 
Expedited review allowed 
 
(   ) 
No review required 
 
 
PERMANENT CLOSURE  
 
The study referenced above was permanently closed effective July 31, 2015, as the accrual has 
been met. 
 
 
cc: 
SELECT Statistical Center Staff - Phyllis Goodman, M.S.; Jo Ann Hartline, M.P.H., M.S.W. 
Elaine Armstrong, M.S. - Quality Assurance 
William Christen, Sc.D. – SEE 
Robert Glynn, Sc.D. - SEE 
 
              
Operations Office 
4201 Medical Drive, Suite 250, San Antonio, TX 78229 • Telephone 210-614-8808 • FAX 210-614-0006 • http://www.swog.org 


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