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antioxidants

Phase 2

Central Serous Chorioretinopathy | Small molecule | Other |Alcon Inc.|Last Updated: Dec 30, 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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00963131High-dose Antioxidants for Central Serous ChorioretinopathyPHASE2 COMPLETED 60Dec 1, 2004Jun 1, 2009Dec 30, 20091 Thailand
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Study Endpoints
Primary Endpoints
visual acuity and central macular thickness
6 months
Secondary Endpoints
fluorescein leakage at the third month
6 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
antioxidant tabletsEXPERIMENTALthe study arm received antioxidant tablets (Icaps) for 3 months or until the resolution of the disease
placebo tabletsPLACEBO_COMPARATORthe control arm received placebo tablets for 3 months or until the resolution of the disease
Interventions
NameTypeDescription
antioxidants tabletsDRUGvitamin A 6600 IU, vitamin C 400 mg, vitamin E 150 IU, riboflavin 10 mg, zinc 60 mg, copper 4 mg, selenium 40 mg, manganese 4 mg and lutein/zeaxanthin 4000 micrograms.
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Eligibility Criteria
Age Range30 Years — 50 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. patients with acute central serous chorioretinopathy within 6 weeks of onset 2. age between 30-50 years 3. new or recurrent attack (the symptom-free period should longer than 6 months) 4. fluorescein angiography (FA) confirmed the diagnosis with the inkblot or smoke-stack lea...

Countries:Thailand
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