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

Macular Edema Clinical Trial

— DOGWOOD  

Official title:

A Randomized, Masked, Multicenter Study to Assess the Safety and Efficacy of CLS-TA, Triamcinolone Acetonide Injectable Suspension in the Treatment of Subjects With Macular Edema Following Uveitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02255032
• Other study ID #: CLS1001-201
• Status: Completed
• Phase: Phase 2
• Start date: October 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2021
• Source: Clearside Biomedical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Panuveitis
• Uveitis
• Uveitis, Anterior
• Uveitis, Intermediate
• Uveitis, Posterior

Intervention

Drug:
• 4 mg CLS-TA
40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
• 0.8 mg CLS-TA
8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clearside Biomedical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Central Subfield Thickness, Measured Using Optical Coherence Tomography, After Treatment With CLS-TA in Subjects With Macular Edema Following Uveitis		2 months