Suprachoroidal Injection of CLS-TA in Subjects Non-infectious Uveitis (AZALEA)

• ClinicalTrials.gov Identifier: NCT03097315
• Recruitment Status: Completed
• First Posted: March 31, 2017
• Last Update Posted: September 18, 2018
• Sponsor: Clearside Biomedical, Inc.
• Information provided by (Responsible Party): Clearside Biomedical, Inc.

Study Description

Brief Summary:

Open-label safety study of suprachoroidal triamcinolone acetone injectable suspension in patients with non-infectious uveitis.

Condition or disease	Intervention/treatment	Phase
Uveitis; Uveitis, Posterior; Uveitis, Anterior; Uveitis, Intermediate; Panuveitis	Combination Product: 4mg CLS-TA Suprachoriodal Injection	Phase 3

Detailed Description:

This is a Phase 3, open-label, multi-center study to assess the safety of 4 mg of CLS-TA administered via suprachoroidal injection for the treatment of subjects with non-infectious uveitis.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 38 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-label Safety Study of Suprachoroidal Triamcinolone Acetonide Injectable Suspension in Patients With Non-Infectious Uveitis
• Actual Study Start Date: April 1, 2017
• Actual Primary Completion Date: January 24, 2018
• Actual Study Completion Date: January 24, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 4mg CLS-TA Suprachoriodal Injection; Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA	Combination Product: 4mg CLS-TA Suprachoriodal Injection; CLS-TA, 4 mg in 100 microliters, will be administered as a single injection at 2 timepoints; Other Name: Triamcinolone Acetonide

Outcome Measures

Primary Outcome Measures :

1. Adverse Events [ Time Frame: 24 weeks ]
   Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), grouped by organ system, relatedness to study medication, and severity

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Diagnosis of 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
• Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study

Contacts and Locations

Locations

United States, Arizona

Retinal Consultants of Arizona

Phoenix, Arizona, United States, 85014

United States, California

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States, 90211

Northern California Retina Vitreous Associates Medical Group, Inc.

Mountain View, California, United States, 94040

United States, Florida

Retina Group of Florida

Fort Lauderdale, Florida, United States, 33308

United States, Georgia

Marietta Eye Clinic

Marietta, Georgia, United States, 30060

United States, Indiana

Midwest Eye Retina Practicing at Midwest Eye Institute

Indianapolis, Indiana, United States, 46290

United States, Massachusetts

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States, 02114

United States, Texas

Texas Retina Associates

Dallas, Texas, United States, 75231

Retina Consultants of Houston

Houston, Texas, United States, 77030

United States, Virginia

Virginia Eye Consultants

Norfolk, Virginia, United States, 23502

Sponsors and Collaborators

Clearside Biomedical, Inc.

Investigators

• Study Director: Jennifer Kissner, PhD; Clearside Biomedical, Inc.

More Information

• Responsible Party: Clearside Biomedical, Inc.
• ClinicalTrials.gov Identifier: NCT03097315 History of Changes
• Other Study ID Numbers: CLS1001-302
• First Posted: March 31, 2017
• Last Update Posted: September 18, 2018
• Last Verified: June 2017

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: No
• Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Clearside Biomedical, Inc.:

Uveitis; UME; Posterior Uveitis; Anterior Uveitis; Intermediate Uveitis; Panuveitis; Non-infectious Uveitis; Triamcinolone; Choroid; Choroidal Injection; Suprachoroidal; Microneedle; Microinjection

Additional relevant MeSH terms:

Uveitis; Panuveitis; Uveitis, Posterior; Uveitis, Intermediate; Pars Planitis; Uveitis, Anterior; Uveal Diseases; Eye Diseases; Choroiditis; Choroid Diseases; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action