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Macugen

Phase 2

Macular Edema Associated With Diabetes Mellitus | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Nov 16, 2018

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-BlindSHAM_CONTROLLED
Total Trials1
Total Enrollment317
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00605280A Multi-Center Trial To Evaluate The Safety And Efficacy Of Pegaptanib Sodium(Macugen) Injected Into The Eye Every 6 Weeks For Up To 2 Years For Macular Swelling Associated With Diabetes, With An Open-Label Macugen Year Extension.PHASE2 COMPLETED 317 — — Sep 1, 2005Jul 1, 2011Nov 16, 201873 United States, Australia +16
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Study Endpoints
Primary Endpoints
Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year
Baseline, Year 1

Refraction and best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts

Secondary Endpoints
Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years
Baseline, Year 2
Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year
Baseline, Year 1
Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years
Baseline, Year 2
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sham ControlSHAM_COMPARATOR -
MacugenEXPERIMENTAL -
Interventions
NameTypeDescription
Standard of CareDRUGClinicians decision to use optional laser therapy.
MacugenDRUGIntravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites73

Inclusion Criteria: * macular edema associated with diabetes * visual acuity between 20/50 and 20/200 Exclusion Criteria: * recent laser therapy in the eye * recent signs of uncontrolled diabetes * blood pressure worse than 160/100 * severe cardiac disease

Countries:United StatesAustraliaAustriaBrazilCanadaColombiaCzechiaDenmarkFranceGermanyGreeceIndiaItalyNetherlandsPortugalSouth AfricaSwitzerlandUnited Kingdom
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