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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Clearside Biomedical, Inc.
Sponsor:
Information provided by (Responsible Party):
Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier:
NCT02595398
First received: October 28, 2015
Last updated: March 22, 2017
Last verified: March 2017
  Purpose
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 Intervention Phase
Uveitis
Uveitis, Posterior
Uveitis, Anterior
Uveitis, Intermediate
Panuveitis
Drug: 4mg CLS-TA Suprachoriodal Injection
Drug: Sham Procedure
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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:
  • 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

  • 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


Estimated Enrollment: 150
Study Start Date: November 2015
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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, 4 mg in 100 microliters, 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

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).

  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 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
  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: NCT02595398

Contacts
Contact: Ellie Smith ellie.smith@clearsidebio.com
Contact: Nichole Wilkes nichole.wilkes@clearsidebio.com

  Show 66 Study Locations
Sponsors and Collaborators
Clearside Biomedical, Inc.
Investigators
Study Director: Jennifer Kissner, PhD Clearside Biomedical, Inc.
  More Information

Responsible Party: Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT02595398     History of Changes
Other Study ID Numbers: CLS1001-301
Study First Received: October 28, 2015
Last Updated: March 22, 2017

Keywords provided by Clearside Biomedical, Inc.:
Uveitis
UME
Posterior Uveitis
Anterior Uveitis
Intermediate Uveitis
Panuveitis
Non-infectious Uveitis
Triamcinolone
Choroid
Choroidal Injection
Suprachoroidal
Microneedle
Microinjection

Additional relevant MeSH terms:
Macular Edema
Uveitis
Panuveitis
Uveitis, Intermediate
Pars Planitis
Uveitis, Posterior
Uveitis, Anterior
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Uveal Diseases
Choroiditis
Choroid Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
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 March 24, 2017