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CLS-TA

Phase 2

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

CLS-TA target and mechanism

ModalitySmall molecule

Also known as SC CLS-TA

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment68

FDA Designations

No designations recorded

CLS-TA clinical trials

CLS-TA · 2 trials · 7 indications

Phase 2 2
NCT02303184Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVOMacular Edema
COMPLETED46 Analytics
NCT02255032Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious UveitisUveitis
COMPLETED22 Analytics
PHASE2COMPLETED
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO
Macular EdemaUnlock trial analytics
PHASE2COMPLETED
Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis
UveitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm
3 months
Change From Baseline in Central Subfield Thickness, Measured Using Optical Coherence Tomography, After Treatment With CLS-TA in Subjects With Macular Edema Following Uveitis
2 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
4 mg CLS-TAEXPERIMENTALSingle unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
0.8 mg CLS-TAEXPERIMENTALSingle unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA

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
0.8 mg CLS-TADRUG8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
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Eligibility Criteria

Age Range18 Years to 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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Frequently asked questions about CLS-TA

What is CLS-TA?

CLS-TA is an investigational small molecule therapy being developed by Clearside Biomedical, Inc. for ophthalmic conditions. It is a formulation of triamcinolone acetonide designed for suprachoroidal injection, a targeted delivery approach to the back of the eye. It is in Phase 2 clinical development for macular edema associated with uveitis and retinal vein occlusion.

What is CLS-TA used for?

CLS-TA is being studied for the treatment of macular edema, including macular edema following retinal vein occlusion and macular edema associated with non-infectious uveitis. These are inflammatory and vascular conditions of the eye that cause fluid accumulation in the macula. CLS-TA remains investigational and has not been approved for commercial use.

Who is developing CLS-TA?

CLS-TA is being developed by Clearside Biomedical, Inc., which trades under the ticker CLSD. The company is advancing the candidate as a suprachoroidally administered therapy for macular edema associated with retinal vein occlusion and non-infectious uveitis.

What phase is CLS-TA in?

CLS-TA is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 2 program includes completed trials in macular edema following retinal vein occlusion and in macular edema associated with non-infectious uveitis.

What clinical trials is CLS-TA in?

CLS-TA has been evaluated in two completed Phase 2 trials. NCT02303184 studied suprachoroidal injection of triamcinolone acetonide with intravitreal aflibercept in 46 subjects with macular edema following retinal vein occlusion. NCT02255032 studied suprachoroidal triamcinolone acetonide in 22 subjects with macular edema following non-infectious uveitis.