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fluocinolone acetonide

Phase 2

Diabetic Macular Edema | Small molecule | Other |Bausch + Lomb Corporation|Last Updated: Nov 28, 2013

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-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment196
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00502541Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular EdemaPHASE2 COMPLETED 196Sep 1, 2001Sep 1, 2006Nov 28, 2013 -
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Study Endpoints
Primary Endpoints
A change from baseline in visual acuity using ETDRS charts • Humphrey Visual Field Mean Defect (24-2) • Masked reading of the size of the area of retinal thickening on color photographs and OCT, where available, and of severity of fluorescein leakage
at 26 weeks and yearly through completion of the study
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Fluocinolone acetonideEXPERIMENTALFluocinolone acetonide intravitreal implant
Standard of CareACTIVE_COMPARATORStandard of care
Interventions
NameTypeDescription
fluocinolone acetonideDRUGfluocinolone acetonide 0.59 mg intravitreal implant
Standard of CarePROCEDURERepeat macular grid laser or observation
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Males and nonpregnant females at least 18 years of age, with DME in the study eye * Edema must involve fixation and be at least 1 disc area in size * Visual acuity of ≥20 and ≤68 letters by ETDRS in the study eye * The study eye must have received at least one macular laser tr...

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