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

Clearside Biomedical

Status and phase: Completed; Phase 3

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

Treatments: Drug: 4 mg CLS-TA Suprachoriodal Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03097315

CLS1001-302

Details and patient eligibility

About

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.

Full 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).

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

4 mg CLS-TA Suprachoriodal Injection

Experimental group

Description:

Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA

Treatment:

Drug: 4 mg CLS-TA Suprachoriodal Injection