Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis

Phase 1

Completed

• Conditions: Posterior Uveitis; Noninfectious Uveitis; Intermediate Uveitis; Panuveitis; Uveitis
• Interventions: Drug: triamcinolone acetonide (Triesence®)

• Registration Number: NCT01789320
• Lead Sponsor: Clearside Biomedical, Inc.

Brief Summary

This study is designed to determine the safety and tolerability of a single microinjection of triamcinolone acetonide (TRIESENCE®) into the suprachoroidal space (SCS) of patients who have non-infectious uveitis.

Detailed Description

This is a Phase 1/2, open-label study designed to evaluate the safety, tolerability and procedure of a microneedle injection of triamcinolone acetonide (TA) into the SCS. The subjects enrolled in this study will be chosen from subjects with non-infectious intermediate, posterior and pan-uveitis. The injection will only be administered to a single eye via the Clearside Biomedical proprietary microneedle into the SCS. The dose of TA to be injected is 4 mg of currently approved TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL). The study design includes 10 clinic visits over 27 weeks. Subjects will be followed for 26 weeks following treatment with TRIESENCE®.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-12
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Disposition First Submitted: 2016-07-25
• Disposition First Submitted QC: 2016-07-25
• Disposition First Posted: 2016-07-28
• Results First Submitted: 2021-01-18
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-17
• Last Update Submitted: 2021-02-17
• Results First Posted: 2021-02-21
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 treatment, or any prior use of Retisert™ in the study eye
• any uncontrolled systemic disease that would preclude participation in the study or put the subject at risk due to study treatment or procedures
• have a known HIV infection or other immunodeficiency disease for which corticosteroid therapy would be contraindicated
• are monocular
• have ocular hypertension
• history of any intraocular surgery in the study eye
• presence of an anterior staphyloma in the study eye

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Central Subfield Thickness Using Optical Coherence Tomography (OCT)	Change from baseline at 8 weeks and 26 weeks.	Central subfield thickness (CST) is a measure of the thickness of the retina in the 1 mm diameter circle centered on the fovea or center of the macular where eyesight is the sharpest. CST change from baseline at 8 and 26 weeks was measured using optical coherence tomography (OCT). OCT is a diagnostic imaging technique used to capture 2 and 3 dimensional images within biological tissue, e.g., for determining the amount of edema contained in the retina. CST is typically measured in microns. A negative change represents a reduction in retinal thickness and an improvement in cases of retinal edema.
Vitreous Haze Grade	Change from baseline at 8 weeks and 26 weeks	Vitreous haze scale (Nussenblatt 1985 as modified in Lowder 2011). Scores include value 0 (no inflammation), +0.5 (trace inflammation), +1 (mild blurring of the retinal vessels and optic nerve), +1.5 (optic nerve head and posterior retina view obscuration greater than +1 but less than +2), +2 (moderate blurring of the optic nerve head), +3 (marked blurring of the optic nerve head), and +4 (optic nerve head not visible) A higher score indicates a worse outcome.

Trial Locations

Locations (3)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States