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Choline Fenofibrate

Phase 2

Diabetic Macular Edema | Small molecule | Other |Abbott Laboratories|Last Updated: Aug 26, 2011

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment110
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00683176Effect of Choline Fenofibrate (SLV348) on Macular EdemaPHASE2 COMPLETED 110Sep 1, 2008Mar 1, 2011Aug 26, 201121 Bulgaria, Czechia +8
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Study Endpoints
Primary Endpoints
Total macular volume measurement on OCT, after central reading (assessed at baseline and after 3, 6, 9 and 12 months of treatment)
12 months
Secondary Endpoints
OCT variables (Retinal Thickness, Retinal thickening)
12 months
ETDRS macular and hard exudate grading, E-ETDRS visual acuity, ETDRS retina grading, at least 2 step progression, Laser photocoagulation for diabetic macular edema
12 months
Lipids
12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATOR -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Choline FenofibrateDRUG135 mg
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range30 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria * With DME in at least one eye of the subject and this eye presenting with macula thickness ≥ 300 µm on OCT examination at baseline in at least one of the 5 following zones: center zone, or superior inner zone, or nasal inner zone, or inferior inner zone, or temporal inner zone, ...

Countries:BulgariaCzechiaDenmarkGermanyHungaryItalyNetherlandsPolandSpainUnited Kingdom
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