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Danazol

Phase 2

Diabetic Macular Edema | Small molecule | Other |Unity Biotechnology, Inc.|Last Updated: Dec 6, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02002403Efficacy and Safety Study to Evaluate Two Doses of Oral DMI-5207 in Adult Subjects With Diabetic Macular EdemaPHASE2 COMPLETED 34Jan 1, 2011Apr 1, 2012Dec 6, 2013 -
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Study Endpoints
Primary Endpoints
OCT
12 weeks

Change in Central Macular Thickness (CMT), measured by time-domain optical coherence tomography (OCT), from baseline to study endpoint at 12 weeks of study treatment compared to placebo

Secondary Endpoints
ETDRS BCVA
12 weeks
Retinal volume
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
Optina Low DoseEXPERIMENTALOptina, 15 mg orally, twice daily
Optina - High DoseEXPERIMENTALOptina, 45 mg orally, twice daily
Interventions
NameTypeDescription
DanazolDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Patient has provided informed consent 2. Male or female 18 years or older with Type 1 or 2 diabetes mellitus \[defined as a selfreport of diabetes accompanied by treatment (insulin or diet) or a history of fasting plasma glucose ≥ 7.0mmo/l (126mg/dl) or 2-hr plasma glucose ≥1...

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