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

• ClinicalTrials.gov Identifier: NCT02255032
• Recruitment Status: Completed
• First Posted: October 2, 2014
• Results First Posted: February 8, 2021
• Last Update Posted: February 8, 2021
• Sponsor: Clearside Biomedical, Inc.
• Information provided by (Responsible Party): Clearside Biomedical, Inc.

Tracking Information

• First Submitted Date: September 30, 2014
• First Posted Date: October 2, 2014
• Results First Submitted Date: January 18, 2021
• Results First Posted Date: February 8, 2021
• Last Update Posted Date: February 8, 2021
• Study Start Date: October 2014
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 30, 2014): Change From Baseline in Central Subfield Thickness, Measured Using Optical Coherence Tomography, After Treatment With CLS-TA in Subjects With Macular Edema Following Uveitis [ Time Frame: 2 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis
• 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
• Brief 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.

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
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

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

Intervention

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

Study Arms

• Experimental: 4 mg CLS-TA
  Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
  Intervention: Drug: 4 mg CLS-TA
• Experimental: 0.8 mg CLS-TA
  Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA
  Intervention: Drug: 0.8 mg CLS-TA

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 18, 2016): 22
• Original Estimated Enrollment (submitted: September 30, 2014): 28
• Actual Study Completion Date: January 2016
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02255032
• Other Study ID Numbers: CLS1001-201
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Clearside Biomedical, Inc.
• Study Sponsor: Clearside Biomedical, Inc.
• Collaborators: Not Provided

Investigators

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

• PRS Account: Clearside Biomedical, Inc.
• Verification Date: January 2021