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1,2 dithiolane 3 valeric acid

Phase 3

Diabetes Mellitus | Small molecule | Metabolic |Bausch + Lomb Corporation|Last Updated: Sep 24, 2010

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 Enrollment520
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01208948Clinical Trial on Alpha Lipoic Acid in Diabetic Macular EdemaPHASE3 COMPLETED 520Jul 1, 2000Dec 1, 2005Sep 24, 20101 Germany
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Study Endpoints
Primary Endpoints
occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years
two years
Secondary Endpoints
The time to CSME development
two years
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Alpha lipoic acid 600 mgACTIVE_COMPARATOR -
placebo pillPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
1,2 dithiolane 3 valeric acidDRUG600 mg alpha lipoic acid per day
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Eligibility Criteria
Age Range45 Years — 68 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diabetes type II, mild non proliferative diabetic retinopathy, * Microalbuminuria \> 30 mg/L Exclusion Criteria: Ophthalmic exclusion criteria * severe non-proliferative or proliferative diabetic retinopathy * Macular edema * Eye diseases interfering with the examinations o...

Countries:Germany
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