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triamcinolone acetonide

Phase 1

Uveitis | Small molecule | Ophthalmology |Clearside Biomedical, Inc.|Last Updated: Feb 21, 2021

Target and mechanism

ModalitySmall molecule

Also known as triamcinolone acetonide (Triesence®)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment11

FDA Designations

No designations recorded

Clinical trial landscape

triamcinolone acetonide · 1 trial · 5 indications

Phase 1 1
NCT01789320Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat UveitisUveitis
COMPLETED11 Analytics
PHASE1COMPLETED
Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis
UveitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Intraocular Pressure (IOP)
Change from baseline in IOP at 8 weeks

Intraocular pressure is the fluid pressure inside the eye. Intraocular pressure change from baseline at week 8 was measured by Goldmann applanation tonometry. Tonometry is the method eye care professionals use to determine this pressure. Intraocular pressure is typically measured in millimeters of mercury. A higher pressure inside the eye can be a risk factor for developing glaucoma or glaucoma progression leading to optic nerve damage. A negative change indicates a reduction in intraocular pressure.

Best Corrected Visual Acuity
Change from baseline at 8 weeks and 26 weeks.

Visual acuity (VA) rates a person's ability to recognize small details with precision. Best corrected VA refers to this measurement when the best vision has be achieved following refraction. Visual acuity change from baseline at 8 and 26 weeks was measured following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol using standardized lighting and lanes and an ETDRS eye chart. This eye chart comprises rows of letters, with 5 letters per row, and with the letter size from line to line varying logarithmically and is used to estimate visual acuity. Visual acuity is scored with reference to the logarithm of the minimum angle of resolution or logMAR. Zero logMAR indicates standard vision, positive values indicate poor vision and negative values indicate good vision. A negative changes indicates an improvement in visual acuity.

Secondary Endpoints

Central Subfield Thickness Using Optical Coherence Tomography (OCT)
Change from baseline at 8 weeks and 26 weeks.
Vitreous Haze Grade
Change from baseline at 8 weeks and 26 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
triamcinolone acetonide (Triesence®)EXPERIMENTALTRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS)

Interventions

NameTypeDescription
triamcinolone acetonide (Triesence®)DRUG4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * diagnosis of non-infectious intermediate, posterior or pan-uveitis Exclusion Criteria: * any ocular trauma within the past 6 months in the study eye * any injection of intraocular corticosteroids or steroid implant or the Ozurdex® implant in the 6 months prior to the study t...

Countries:United States
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Competitive Landscape -Uveitis 5 trials