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Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis (PEACHTREE)

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ClinicalTrials.gov Identifier: NCT02595398
Recruitment Status : Active, not recruiting
First Posted : November 3, 2015
Last Update Posted : August 8, 2017
Information provided by (Responsible Party):
Clearside Biomedical, Inc.

Brief Summary:
The study is designed to evaluate the safety and efficacy of suprachoroidally administered triamcinolone acetonide, CLS-TA, in subjects with macular edema associated with non-infectious uveitis.

Condition or disease Intervention/treatment Phase
Uveitis Uveitis, Posterior Uveitis, Anterior Uveitis, Intermediate Panuveitis Drug: 4mg CLS-TA Suprachoriodal Injection Drug: Sham Procedure Phase 3

Detailed Description:

This is a Phase 3, randomized, masked, sham-controlled, multicenter study to assess the safety and efficacy of 4 mg of CLS-TA administered via suprachoroidal injection compared to a sham injection procedure in the treatment of subjects with macular edema associated with non-infectious uveitis.

Qualified subjects will be randomized to receive two suprachoroidal injections of CLS-TA administered to the study eye or two sham injection procedures administered to the study eye approximately 12 weeks apart (Visit 2 and Visit 5). Follow-up visits will be conducted monthly up to 24 weeks (Visit 8).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Masked, Controlled Clinical Trial to Study the Safety and Efficacy of Triamcinolone Acetonide Injectable Suspension (CLS-TA) for the Treatment of Subjects With Macular Edema Associated With Non-infectious Uveitis
Study Start Date : November 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Arm Intervention/treatment
Experimental: 4mg CLS-TA Suprachoriodal Injection
Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
Drug: 4mg CLS-TA Suprachoriodal Injection
CLS-TA, 40 mg/mL (4 mg in 100 µL), will be administered as a single injection at 2 timepoints
Other Name: Triamcinolone Acetonide
Sham Comparator: Sham Procedure
Matching suprachoroidal syringe with sham procedure
Drug: Sham Procedure
Sham procedure will be administered at 2 timepoints

Primary Outcome Measures :
  1. Best Corrected Visual Acuity (BCVA) using ETDRS electronic visual acuity (eVA). [ Time Frame: baseline to 24 weeks ]
    Proportion of subjects with a change from baseline of ≥ 15 letters in ETDRS BCVA at Visit 8 (24 weeks), subsequent to suprachoroidal injections of CLS-TA or sham injection procedures, in the study eye

Secondary Outcome Measures :
  1. Change in Macular Edema [ Time Frame: baseline to 24 weeks ]
    Mean change from baseline in Central Subfield Thickness (CST) as measured by SD-OCT at 24 weeks

  2. Adverse Events [ Time Frame: baseline to 24 weeks ]
    Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), grouped by organ system, relatedness to study medication, and severity

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of non-infectious uveitis (pan, anterior, intermediate and posterior)
  • Diagnosis of macular edema associated with non-infectious uveitis
  • Visual Acuity score of ≥ 5 letters read (20/800 Snellen equivalent) and ≤ 70 letters read (20/40 Snellen equivalent), in the study eye

Exclusion Criteria:

  • Any active ocular disease or infection in the study eye other than uveitis
  • Intraocular pressure > 22 mmHg or uncontrolled glaucoma in the study eye
  • Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02595398

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Sponsors and Collaborators
Clearside Biomedical, Inc.
Study Director: Jennifer Kissner, PhD Clearside Biomedical, Inc.

Responsible Party: Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT02595398     History of Changes
Other Study ID Numbers: CLS1001-301
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

Keywords provided by Clearside Biomedical, Inc.:
Posterior Uveitis
Anterior Uveitis
Intermediate Uveitis
Non-infectious Uveitis
Choroidal Injection

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