Suprachoroidal Injection of CLS-TA in Patients With Non-infectious Uveitis

Clearside Biomedical, Inc.38 enrolled

Overview

This open-label study is designed to evaluate the safety of suprachoroidally administered triamcinolone acetone injectable suspension, CLS-TA, in patients with non-infectious uveitis with and without macular edema.

This is a Phase 3, open-label multicenter study to assess the safety of 4 mg of CLS-TA administered via suprachoroidal injection in the treatment of patients diagnosed with noninfectious uveitis with and without macular edema. Qualified patients will be enrolled and receive two suprachoroidal injections of CLS-TA administered to the study eye approximately 12 weeks apart (Visit 2 and Visit 5). Follow-up visits will be conducted monthly up to 24 weeks (Visit 8).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Uveitis Uveitis, Posterior Uveitis, Anterior Uveitis, Intermediate Panuveitis

Interventions

4 mg CLS-TA Suprachoriodal InjectionDRUG

CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of active or inactive non-infectious uveitis (pan, anterior, intermediate and posterior) * ETDRS BCVA score of ≥ 5 letters read in the study eye Exclusion Criteria: * Any active ocular disease or infection in the study eye other than uveitis * Intraocular pressure \> 22 mmHg or uncontrolled glaucoma in the study eye; patients with IOP of 22 or less in the study eye not excluded with no more than 2 IOP-lowering medications. * Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study * Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years prior to baseline.

Locations (10)

Retinal Consultants of Arizona

Phoenix, Arizona, United States

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Northern California Retina Vitreous Associates Medical Group, Inc.

Mountain View, California, United States

Outcomes

Primary Outcomes

Adverse Events

Number of patients with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a preexisting medical condition after or during exposure to a pharmaceutical product, whether or not considered causally related to the product. A TEAE is an AE occurring on or after the date of the first dose of study drug or worsening relative to the pre-treatment state. An SAE is an AE that fulfils one or more of the following: results in death; is immediately life-threatening; requires hospitalization nor prolongation of hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; or is an important medical event that may jeopardize the subject or may require medical intervention to present one of the outcomes listed above.

Time frame: Baseline to 24 weeks

Secondary Outcomes

Mean Intraocular Pressure in the Study Eye

Intraocular pressure is the fluid pressure inside the eye. Tonometry is the method eye care professionals use to determine this. IOP is an important aspect in the evaluation of patients at risk of glaucoma. Tonometers in this study were calibrated to measure pressure in millimeters of mercury.

Time frame: Baseline, 24 Weeks

Number of Patients With a Grade of 0 in Anterior Chamber Cells in the Study Eye

The anterior chamber is the aqueous humor-filled space inside the eye between the iris and the cornea's innermost surface, the endothelium. The grading of cellular reaction in the anterior chamber helps in the assessment of the severity of uveitis. In this study, anterior chamber cells were graded following the Standardization of Uveitis Nomenclature working group recommendations. The following scale was used to grade the cells in the field: 0 = \<1, 0.5+ = 1-5, 1+ = 6-15, 2+ = 16-25, 3+ = 26-50, and 4+ = \>50 cells. A lower grade represents less inflammation in the eye.

Time frame: Baseline, 24 Weeks

Number of Patients With a Grade of 0 in Anterior Chamber Flare in the Study Eye

Data from ClinicalTrials.gov

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