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Antioxidants, Zinc, Antioxidants and zinc

Phase 3

Macular Degeneration | Unknown | Ophthalmology |Bausch + Lomb Corporation|Last Updated: Jan 23, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindNO_TREATMENT_CONTROLLEDDMC
Total Trials1
Total Enrollment4,757
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00000145Age-Related Eye Disease Study (AREDS)PHASE3 COMPLETED 4,757Sep 1, 1990Dec 1, 2006Jan 23, 2009 -
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Study Endpoints
Primary Endpoints
Progression of age-related macular degeneration
Progression of lens opacity (cataract)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelFACTORIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAntioxidants
2EXPERIMENTALZinc
3EXPERIMENTALAntioxidants and zinc
4NO_INTERVENTION -
Interventions
NameTypeDescription
AntioxidantsDIETARY_SUPPLEMENT500 milligrams vitamin C; 400 IUs vitamin E; 15 milligrams beta-carotene
ZincDIETARY_SUPPLEMENT80 milligrams zinc oxide; 2 milligrams of cupric oxide
Antioxidants and zincDIETARY_SUPPLEMENT500 milligrams vitamin C; 400 IUs vitamin E; 15 milligrams beta-carotene; 80 milligrams zinc oxide; 2 milligrams of cupric oxide
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Eligibility Criteria
Age Range55 Years — 80 Years
SexALL
Healthy VolunteersNo

Men and women between the ages of 55 and 80 years whose macular status ranges from no evidence of AMD in either eye to relatively severe disease with vision loss in one eye but good vision in the fellow eye (20/30 or better) are eligible for the study provided that their ocular media are clear enoug...

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