Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis

Clearside Biomedical

Status and phase: Completed; Phase 2; Phase 1

Conditions: Uveitis; Noninfectious Uveitis; Posterior Uveitis; Intermediate Uveitis; Panuveitis

Treatments: Drug: triamcinolone acetonide (Triesence®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01789320

CLS1001-101

Details and patient eligibility

About

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.

Full 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®.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 Retisert™ 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

triamcinolone acetonide (Triesence®)

Experimental group

Description:

TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS)

Treatment:

Drug: triamcinolone acetonide (Triesence®)