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Octreotide in Microspheres

Phase 3

Diabetic Retinopathy | Small molecule | Ophthalmology |Novartis AG|Last Updated: Nov 17, 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 Trials2
Total Enrollment895
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00130845Octreotide Acetate in Microspheres in Patients With Diabetic RetinopathyPHASE3 COMPLETED 312Feb 1, 2000Dec 1, 2005Nov 17, 20111 United States
NCT00131144Octreotide Acetate in Microspheres in Patients With Diabetic RetinopathyPHASE3 COMPLETED 583Nov 1, 1999Dec 1, 2005Nov 17, 20111 United States
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Study Endpoints
Primary Endpoints
time to progression of diabetic retinopathy
Secondary Endpoints
time to development or progression of macular edema,
time to moderate vision loss
time to development or progression of macular edema, and
Baseline through end of study
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Octreotide Acetate in MicrospheresEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Octreotide Acetate in Microspheres 20 mgEXPERIMENTAL20 mg will be administered im once every 4 weeks
Octreotide Acetate in Microspheres 30 mgEXPERIMENTAL30 mg will be administered im once every 4 weeks
Interventions
NameTypeDescription
Octreotide Acetate in MicrospheresDRUG -
PlaceboDRUG -
Octreotide Acetate in Microspheres 20 mgDRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Males and females with type 1 and type 2 diabetes mellitus * Moderately severe or severe NPDR or mild PDR in at least one eye: * with an Early Treatment Diabetic Retinopathy Study (ETDRS) visual score of \> 35 letters; and * not previously treated with scatter photocoagul...

Countries:United States
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