Clinical trial NCT02255032: Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis
Official title: A Randomized, Masked, Multicenter Study to Assess the Safety and Efficacy of CLS-TA, Triamcinolone Acetonide Injectable Suspension in the Treatment of Subjects With Macular Edema Following Uveitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uveitis
Macular Edema
Uveitis, Posterior
Uveitis, Anterior
Panuveitis
Uveitis, Intermediate
Keywords: uveitis
macular edema
UME
posterior uveitis
anterior uveitis
panuveitis
intermediate uveitis
noninfectious uveitis
triamcinolone acetonide
suprachoroidal space
injection
microneedle
intravitreal injection
corticosteroid
CME
choroid
retina
microinjection
SCS
Lead sponsor: Clearside Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate the safety and efficacy of triamcinolone acetonide, CLS-TA, in subjects with macular edema following non-infectious uveitis. A single suprachoroidal injection of one of two doses of CLS-TA will each be evaluated in subjects with macular edema following non-infectious uveitis.

Detailed description: This is a Phase 2, randomized, masked, multicenter study to assess the safety and efficacy of two different doses of CLS-TA in the treatment of subjects with macular edema following non-infectious uveitis. Each subject will receive a single suprachoroidal injection of CLS-TA.

The subjects enrolled in this study will be chosen from subjects with macular edema following non-infectious uveitis. A single injection will be administered via the Clearside microinjector into the suprachoroidal space. The dose injected will either be 4 mg or 0.8 mg of CLS-TA in a total volume of 100 μL. The dose they receive will depend on what their randomization code dictates.

Subjects will be monitored for safety and efficacy for approximately 8 weeks following treatment.

Eligibility criteria: Inclusion Criteria:

* diagnosis of noninfectious uveitis
* diagnosis of macular edema associated with noninfectious uveitis

Exclusion Criteria:

* any ocular trauma within the immediate 6 months prior to treatment
* any photocoagulation or cryotherapy in the 6 months prior to treatment
* any IVT injection of anti-VEGF treatment in the 2 months prior to treatment
* any eye diseases other than uveitis and ME that could compromise central visual acuity
* any previous suprachoroidal injection of triamcinolone acetonide in the study eye

Primary outcomes:
measure: Change From Baseline in Central Subfield Thickness, Measured Using Optical Coherence Tomography, After Treatment With CLS-TA in Subjects With Macular Edema Following Uveitis
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Waltham
country: United States
state: Massachusetts
city: Omaha
country: United States
state: Nebraska
city: New York
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cleveland
country: United States
state: Ohio
city: Dallas
country: United States
state: Texas
Study officials:
affiliation: Clearside Biomedical, Inc.
name: Thomas Ciulla, MD
role: STUDY_DIRECTOR
References: