Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis

Condition(s) targeted: Uveitis; Intermediate Uveitis; Posterior Uveitis; Panuveitis; Noninfectious Uveitis

Intervention: triamcinolone acetonide (Triesence®) (Drug)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: Clearside Biomedical, Inc.

This study is designed to determine the safety and tolerability of a single microinjection of triamcinolone acetonide (TRIESENCE®) into the suprachoroidal space (SCS) of patients who have non-infectious uveitis.

Official title: Open-Label, Safety and Tolerability Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle in Subjects With Non-Infectious Uveitis

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Incidence of adverse events

Incidence of adverse events

Secondary outcome:

Central subfield thickness using optical coherence tomography (OCT)

Vitreous haze grade

Change in intraocular pressure (IOP)

Detailed description: This is a Phase 1/2, open-label study designed to evaluate the safety, tolerability and procedure of a microneedle injection of triamcinolone acetonide (TA) into the SCS. The subjects enrolled in this study will be chosen from subjects with non-infectious intermediate, posterior and pan-uveitis. The injection will only be administered to a single eye via the Clearside Biomedical proprietary microneedle into the SCS. The dose of TA to be injected is 4 mg of currently approved TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL). The study design includes 10 clinic visits over 27 weeks. Subjects will be followed for 26 weeks following treatment with TRIESENCE®.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- diagnosis of non-infectious intermediate, posterior or pan-uveitis

Exclusion Criteria:

- any ocular trauma within the past 6 months in the study eye

- any injection of intraocular corticosteroids or steroid implant or the Ozurdex®

implant in the 6 months prior to the study treatment, or any prior use of Retisertâ„¢ in the study eye

- any uncontrolled systemic disease that would preclude participation in the study or

put the subject at risk due to study treatment or procedures

- have a known HIV infection or other immunodeficiency disease for which corticosteroid

therapy would be contraindicated

- are monocular

- have ocular hypertension

- history of any intraocular surgery in the study eye

- presence of an anterior staphyloma in the study eye

Northwestern University, Chicago, Illinois 60611, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198, United States

Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

Starting date: February 2013
Last updated: March 26, 2015