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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02595398
Recruitment Status : Completed
First Posted : November 3, 2015
Results First Posted : April 28, 2021
Last Update Posted : April 28, 2021
Sponsor:
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).

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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
Actual Study Start Date : November 17, 2015
Actual Primary Completion Date : January 18, 2018
Actual Study Completion Date : January 18, 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), 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 administered at 2 timepoints
Other Name: suprachoroidal sham




Primary Outcome Measures :
  1. Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) [ Time Frame: 24 weeks ]
    Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on electronic Visual Acuity (eVA). An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.


Secondary Outcome Measures :
  1. Mean Change From Baseline in Central Subfield Thickness [ Time Frame: 24 weeks ]
    Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. Only images that were gradable by the central reading center were included in the analysis.

  2. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Baseline to 24 weeks ]
    Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)



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

Inclusion Criteria:

  • Diagnosis of non-infectious uveitis (pan, anterior, intermediate and posterior)
  • Diagnosis of macular edema associated with non-infectious uveitis (retinal thickness ≥ 300 microns)
  • 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; subjects are not excluded if IOP ≤ 22 mmHg with no more than 2 IOP lowering medications.
  • Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
  • Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years prior to baseline.

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


Locations
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Sponsors and Collaborators
Clearside Biomedical, Inc.
Investigators
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Study Director: Thomas Cuilla, MD, MBA Clearside Biomedical, Inc.
  Study Documents (Full-Text)

Documents provided by Clearside Biomedical, Inc.:
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Responsible Party: Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT02595398    
Other Study ID Numbers: CLS1001-301
First Posted: November 3, 2015    Key Record Dates
Results First Posted: April 28, 2021
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clearside Biomedical, Inc.:
Uveitis
Posterior Uveitis
Anterior Uveitis
Intermediate Uveitis
Non-infectious Uveitis
UME
Panuveitis
Triamcinolone
Choroid
Choroidal Injection
Suprachoroidal
Microneedle
Microinjection
Triamcinolone acetonide
Additional relevant MeSH terms:
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Uveitis
Uveitis, Posterior
Uveitis, Intermediate
Uveitis, Anterior
Macular Edema
Panuveitis
Pars Planitis
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Uveal Diseases
Choroiditis
Choroid Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
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