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CLS-TA

Phase 2

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

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

CLS-TA is an investigational small molecule being developed by Clearside Biomedical for the treatment of macular edema and uveitis. It is administered by suprachoroidal injection. CLS-TA is currently in Phase 2 clinical development and is not yet approved by the FDA.

What does CLS-TA target?

CLS-TA is a formulation of triamcinolone acetonide, a corticosteroid that works by reducing inflammation. It is delivered via suprachoroidal injection to treat conditions like macular edema and uveitis. The drug is being studied for its ability to manage inflammation in the back of the eye.

Who makes CLS-TA?

CLS-TA is being developed by Clearside Biomedical, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CLSD. The company is focused on developing treatments for ophthalmic diseases using its proprietary suprachoroidal injection platform.

What phase is CLS-TA in?

CLS-TA is in Phase 2 clinical development. It has completed two Phase 2 trials, one in patients with macular edema following non-infectious uveitis and another in patients with macular edema following retinal vein occlusion. CLS-TA is investigational and has not received FDA approval.

What clinical trials is CLS-TA in?

CLS-TA has completed two Phase 2 clinical trials. The first, NCT02255032, studied suprachoroidal injection of triamcinolone acetonide in subjects with macular edema following non-infectious uveitis. The second, NCT02303184, evaluated the same injection combined with IVT aflibercept in subjects with macular edema following retinal vein occlusion.

Is CLS-TA the same as triamcinolone acetonide?

CLS-TA is a proprietary formulation of triamcinolone acetonide, a corticosteroid. It is designed for suprachoroidal injection, a targeted delivery method to the back of the eye. While the active ingredient is triamcinolone acetonide, CLS-TA refers specifically to Clearside Biomedical's investigational product.