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

Phase 3

Completed

Conditions: Uveitis, Posterior
Uveitis, Anterior
Uveitis
Uveitis, Intermediate
Panuveitis

Interventions: Drug: 4 mg CLS-TA Suprachoriodal Injection

Registration Number: NCT03097315

Lead Sponsor: Clearside Biomedical, Inc.

Brief Summary: 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.

Detailed Description: 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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 38

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
4 mg CLS-TA Suprachoriodal Injection	4 mg CLS-TA Suprachoriodal Injection	Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA

Primary Outcome Measures

Name	Time	Method
Adverse Events	Baseline to 24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With a Grade of 0 in Vitreous Haze in the Study Eye	Baseline, 24 Weeks	The vitreous body is that part of the eye that fills the space in the center of the eye. The primary purpose of the vitreous body is to keep the center of the eye clear so that light can get to the retina and vision can begin. Vitreous haze involves the obstruction of the back of the eye by vitreous cells and protein exudation. In this study, vitreous haze was graded following a standardized photographic scale ranging from 0 to 4. The following scale was used to grade the vitreous haze: 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, +4 = optic nerve head not visible. A lower grade represents less inflammation in the eye.
Mean Intraocular Pressure in the Study Eye	Baseline, 24 Weeks	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.
Number of Patients With a Grade of 0 in Anterior Chamber Flare in the Study Eye	Baseline, 24 Weeks	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 intraocular inflammation or flare in the anterior chamber helps in the assessment of the severity of uveitis. In this study, anterior chamber flare was graded following the Standardization of Uveitis Nomenclature working group recommendations. The following scale was used to grade the flare: 0 = none, 1+ = faint, 2+ moderate (iris and lens details clear), 3+ = marked (iris and lens details hazy), 4+ = intense (fibrin or plastic aqueous). A lower grade represents less inflammation in the eye.
Number of Patients With a Grade of 0 in Anterior Chamber Cells in the Study Eye	Baseline, 24 Weeks	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.

Trial Locations

Locations (10): Retinal Consultants of Arizona
🇺🇸
Phoenix, Arizona, United States
Northern California Retina Vitreous Associates Medical Group, Inc.
🇺🇸
Mountain View, California, United States
Retina Group of Florida
🇺🇸
Fort Lauderdale, Florida, United States
Marietta Eye Clinic
🇺🇸
Marietta, Georgia, United States
Texas Retina Associates
🇺🇸
Dallas, Texas, United States
Midwest Eye Retina Practicing at Midwest Eye Institute
🇺🇸
Indianapolis, Indiana, United States
Retina-Vitreous Associates Medical Group
🇺🇸
Beverly Hills, California, United States
Retina Consultants of Houston
🇺🇸
Houston, Texas, United States
Virginia Eye Consultants
🇺🇸
Norfolk, Virginia, United States
Ophthalmic Consultants of Boston
🇺🇸
Boston, Massachusetts, United States