Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis (DOGWOOD)

Clearside Biomedical

Status and phase: Completed; Phase 2

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

Treatments: Drug: 0.8 mg CLS-TA; Drug: 4 mg CLS-TA

Study type: Interventional

Funder types: Industry

Identifiers

NCT02255032

CLS1001-201

Details and patient eligibility

About

The study is designed to evaluate the safety and efficacy of triamcinolone acetonide, CLS-TA, in subjects with macular edema following non-infectious uveitis. A single suprachoroidal injection of one of two doses of CLS-TA will each be evaluated in subjects with macular edema following non-infectious uveitis.

Full description

This is a Phase 2, randomized, masked, multicenter study to assess the safety and efficacy of two different doses of CLS-TA in the treatment of subjects with macular edema following non-infectious uveitis. Each subject will receive a single suprachoroidal injection of CLS-TA.

The subjects enrolled in this study will be chosen from subjects with macular edema following non-infectious uveitis. A single injection will be administered via the Clearside microinjector into the suprachoroidal space. The dose injected will either be 4 mg or 0.8 mg of CLS-TA in a total volume of 100 μL. The dose they receive will depend on what their randomization code dictates.

Subjects will be monitored for safety and efficacy for approximately 8 weeks following treatment.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of noninfectious uveitis
• diagnosis of macular edema associated with noninfectious uveitis

Exclusion criteria

• any ocular trauma within the immediate 6 months prior to treatment
• any photocoagulation or cryotherapy in the 6 months prior to treatment
• any IVT injection of anti-VEGF treatment in the 2 months prior to treatment
• any eye diseases other than uveitis and ME that could compromise central visual acuity
• any previous suprachoroidal injection of triamcinolone acetonide in the study eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups

4 mg CLS-TA

Experimental group

Description:

Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA

Treatment:

Drug: 4 mg CLS-TA

0.8 mg CLS-TA

Experimental group

Description:

Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA

Treatment:

Drug: 0.8 mg CLS-TA