Clinical trial NCT01789320: Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis
Official title: Open-Label, Safety and Tolerability Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle in Subjects With Non-Infectious Uveitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Uveitis
Intermediate Uveitis
Posterior Uveitis
Panuveitis
Noninfectious Uveitis
Keywords: uveitis
intermediate uveitis
posterior uveitis
panuveitis
noninfectious uveitis
microneedle
suprachoroidal space
SCS
inflammation
ocular inflammatory conditions
triamcinolone acetonide
TA
Triesence
injection
IVT
intravitreal
corticosteroid
sympathetic ophthalmia
temporal arteritis
vitreous haze
Lead sponsor: Clearside Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-12
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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®.

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

Primary outcomes:
measure: Change in Intraocular Pressure (IOP)
timeFrame: Change from baseline in IOP at 8 weeks
measure: Best Corrected Visual Acuity
timeFrame: Change from baseline at 8 weeks and 26 weeks.
Secondary outcomes:
measure: Central Subfield Thickness Using Optical Coherence Tomography (OCT)
timeFrame: Change from baseline at 8 weeks and 26 weeks.
measure: Vitreous Haze Grade
timeFrame: Change from baseline at 8 weeks and 26 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Clearside Biomedical, Inc.
name: Thomas Ciulla, MD
role: STUDY_DIRECTOR
References:
citation: Goldstein DA, Do D, Noronha G, Kissner JM, Srivastava SK, Nguyen QD. Suprachoroidal Corticosteroid Administration: A Novel Route for Local Treatment of Noninfectious Uveitis. Transl Vis Sci Technol. 2016 Dec 14;5(6):14. doi: 10.1167/tvst.5.6.14. eCollection 2016 Dec.