Open-Label, Safety and Tolerability Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle in Subjects With Non-Infectious Uveitis
Overview
- Phase
- Phase 1
- Intervention
- triamcinolone acetonide (Triesence®)
- Conditions
- Uveitis
- Sponsor
- Clearside Biomedical, Inc.
- Enrollment
- 11
- Locations
- 3
- Primary Endpoint
- Change in Intraocular Pressure (IOP)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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®.
Investigators
Eligibility Criteria
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
Arms & Interventions
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)
Intervention: triamcinolone acetonide (Triesence®)
Outcomes
Primary Outcomes
Change in Intraocular Pressure (IOP)
Time Frame: 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
Time Frame: 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 Outcomes
- 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)