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NCT Number: NCT02255032

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

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Key information

Conditions

Uveitis Choroid Diseases Choroidal Effusions Eye Abnormalities Eye Diseases Macular Degeneration Macular Edema Panuveitis Retinal Degeneration Retinal Diseases Uveal Diseases Uveitis, Anterior Uveitis, Intermediate Uveitis, Posterior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4 mg CLS-TA

Drug

40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)

0.8 mg CLS-TA

Drug

8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Clearside Biomedical, Inc.

Industry

Registry information

Official study 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

Acronym: DOGWOOD

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 2, 2014
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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