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CLS-TA

Phase 2

Macular Edema | Small molecule | Ophthalmology |Clearside Biomedical, Inc.|Last Updated: Feb 8, 2021

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment46
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02303184Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVOPHASE2 COMPLETED 46Jan 1, 2015Mar 1, 2016Feb 8, 202114 United States
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Study Endpoints
Primary Endpoints
Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm
3 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
4 mg CLS-TA + IVT afliberceptEXPERIMENTALSingle unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept
sham + IVT afliberceptACTIVE_COMPARATORSingle unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept
Interventions
NameTypeDescription
4 mg CLS-TADRUG40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
ShamDRUGsuprachoroidal sham procedure
IVT afliberceptDRUG2 mg intravitreal injection of aflibercept
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * diagnosis of macular edema following RVO * History of ME ≤ 12 months * 20-70 letters inclusive BCVA using ETDRS Exclusion Criteria: * has had an IVT injection of anti-VEGF for RVO in the study eye * has had a corticosteroid injection in the past 3 months in the study eye * a...

Countries:United States
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