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

Uveitis Clinical Trial

— AZALEA  

Official title:

Open-label Safety Study of Suprachoroidal Triamcinolone Acetonide Injectable Suspension in Patients With Non-Infectious Uveitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097315
• Other study ID #: CLS1001-302
• Status: Completed
• Phase: Phase 3
• Start date: April 4, 2017
• Est. completion date: January 24, 2018

Study information

• Verified date: June 2021
• Source: Clearside Biomedical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 24, 2018
• Est. primary completion date: January 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Panuveitis
• Uveitis
• Uveitis, Anterior
• Uveitis, Intermediate
• Uveitis, Posterior

Intervention

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

Locations

Country	Name	City	State
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Texas Retina Associates	Dallas	Texas
United States	Retina Group of Florida	Fort Lauderdale	Florida
United States	Retina Consultants of Houston	Houston	Texas
United States	Midwest Eye Retina Practicing at Midwest Eye Institute	Indianapolis	Indiana
United States	Marietta Eye Clinic	Marietta	Georgia
United States	Northern California Retina Vitreous Associates Medical Group, Inc.	Mountain View	California
United States	Virginia Eye Consultants	Norfolk	Virginia
United States	Retinal Consultants of Arizona	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Clearside Biomedical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. Review. — View Citation

Lowder C, Belfort R Jr, Lightman S, Foster CS, Robinson MR, Schiffman RM, Li XY, Cui H, Whitcup SM; Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol. 2011 May;129(5):545-53. doi: 10.1001/archophthalmol.2010.339. Epub 2011 Jan 10. — View Citation

Nussenblatt RB, Palestine AG, Chan CC, Roberge F. Standardization of vitreal inflammatory activity in intermediate and posterior uveitis. Ophthalmology. 1985 Apr;92(4):467-71. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 24 weeks
Secondary	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.	Baseline, 24 Weeks
Secondary	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.	Baseline, 24 Weeks
Secondary	Number of Patients With a Grade of 0 in Anterior Chamber Flare 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 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.	Baseline, 24 Weeks
Secondary	Number of Patients With a Grade of 0 in Vitreous Haze in the Study Eye	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.	Baseline, 24 Weeks