This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier:
NCT02255032
First received: September 30, 2014
Last updated: March 18, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Uveitis Macular Edema Uveitis, Posterior Uveitis, Anterior Panuveitis Uveitis, Intermediate Drug: 4 mg CLS-TA Drug: 0.8 mg CLS-TA Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Clearside Biomedical, Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 22
Study Start Date: October 2014
Study Completion Date: January 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
4 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
0.8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02255032

Locations
United States, Florida
Miami, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Massachusetts
Boston, Massachusetts, United States
Cambridge, Massachusetts, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New York
New York, New York, United States
United States, North Carolina
Winston Salem, North Carolina, United States
United States, North Dakota
Fargo, North Dakota, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Texas
Dallas, Texas, United States
Sponsors and Collaborators
Clearside Biomedical, Inc.
Investigators
Study Director: Glenn Noronha, PhD Clearside Biomedical, Inc.
  More Information

Responsible Party: Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT02255032     History of Changes
Other Study ID Numbers: CLS1001-201
Study First Received: September 30, 2014
Last Updated: March 18, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Clearside Biomedical, Inc.:
uveitis
macular edema
UME
posterior uveitis
anterior uveitis
panuveitis
intermediate uveitis
noninfectious uveitis
triamcinolone acetonide
suprachoroidal space
injection
microneedle
intravitreal injection
corticosteroid
CME
choroid
retina
microinjection
SCS

Additional relevant MeSH terms:
Edema
Macular Edema
Uveitis
Panuveitis
Uveitis, Posterior
Uveitis, Intermediate
Pars Planitis
Uveitis, Anterior
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Uveal Diseases
Choroiditis
Choroid Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017