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

Primary Purpose

Uveitis, Macular Edema, Uveitis, Posterior

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
4 mg CLS-TA
0.8 mg CLS-TA
Sponsored by
Clearside Biomedical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitis focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

4 mg CLS-TA

0.8 mg CLS-TA

Arm Description

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

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

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
September 30, 2014
Last Updated
January 18, 2021
Sponsor
Clearside Biomedical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02255032
Brief Title
Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clearside Biomedical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Macular Edema, Uveitis, Posterior, Uveitis, Anterior, Panuveitis, Uveitis, Intermediate
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4 mg CLS-TA
Arm Type
Experimental
Arm Description
Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
Arm Title
0.8 mg CLS-TA
Arm Type
Experimental
Arm Description
Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA
Intervention Type
Drug
Intervention Name(s)
4 mg CLS-TA
Intervention Description
40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
Intervention Type
Drug
Intervention Name(s)
0.8 mg CLS-TA
Intervention Description
8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Ciulla, MD
Organizational Affiliation
Clearside Biomedical, Inc.
Official's Role
Study Director
Facility Information:
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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