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

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

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.

Study Overview

• Status: Completed
• Conditions: Uveitis, Anterior; Panuveitis; Uveitis; Macular Edema; Uveitis, Posterior; Uveitis, Intermediate
• Intervention / Treatment: Drug: 4 mg CLS-TA; Drug: 0.8 mg CLS-TA

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
  • Georgia
    • Atlanta, Georgia, United States, 30322
  • Illinois
    • Chicago, Illinois, United States, 60611
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
    • Waltham, Massachusetts, United States, 02451
  • Nebraska
    • Omaha, Nebraska, United States, 68105
  • New York
    • New York, New York, United States, 10021
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
  • North Dakota
    • Fargo, North Dakota, United States, 58103
  • Ohio
    • Cleveland, Ohio, United States, 44195
  • Texas
    • Dallas, Texas, United States, 75231

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4 mg CLS-TA; Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA	Drug: 4 mg CLS-TA; 40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
Experimental: 0.8 mg CLS-TA; Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA	Drug: 0.8 mg CLS-TA; 8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Clearside Biomedical, Inc.
• Investigators: Study Director: Thomas Ciulla, MD, Clearside Biomedical, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: September 30, 2014
• First Submitted That Met QC Criteria: September 30, 2014
• First Posted (Estimate): October 2, 2014

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: January 18, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: macular edema; intravitreal injection; corticosteroid; uveitis; SCS; intermediate uveitis; panuveitis; posterior uveitis; anterior uveitis; retina; triamcinolone acetonide; choroid; injection; CME; microinjection; noninfectious uveitis; microneedle; suprachoroidal space; UME
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Uveal Diseases; Choroid Diseases; Macular Degeneration; Choroiditis; Macular Edema; Edema; Uveitis; Uveitis, Posterior; Panuveitis; Uveitis, Intermediate; Pars Planitis; Uveitis, Anterior
• Other Study ID Numbers: CLS1001-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO