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

May 4, 2021 updated by: Clearside Biomedical, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Kolkata, India, 700027
        • Calcutta Medical Research Institute
      • Kolkata, India
        • Disha Eye Hospital
      • New Delhi, India, 110029
        • Dr Rajendra Prasad Centre for Ophthalmic Sciences
      • New Delhi, India
        • Dr. Shroff's Charity Eye Hospital
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India
        • L V Prasad Eye Hospital
    • Assam
      • Guwahati, Assam, India
        • Sri Sankaradeva Nethralaya
    • Gujarat
      • Ahmedabad, Gujarat, India
        • M&J Western Regional Institute of Ophthalmology
    • Karnataka
      • Mysore, Karnataka, India
        • JSS Hospital
    • Kerala
      • Thiruvananthapuram, Kerala, India
        • Regional Institute of Ophthalmology
    • Maharashtra
      • Mumbai, Maharashtra, India
        • TN Medical College and BYL Nair Hospital
      • Pune, Maharashtra, India
        • PBMA's H V Desai Eye Hospital
    • Tamil Nadu
      • Chennai, Tamil Nadu, India
        • Sankara Nethralaya
      • Coimbatore, Tamil Nadu, India
        • Sankara Eye Hospital
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India
        • King George's Medical University
      • Lucknow, Uttar Pradesh, India
        • Sanjay Gandhi Postgraduate Institute of Medical Sciences
      • Noida, Uttar Pradesh, India
        • Icare Eye Hospital & PG Institute
  • Israel
      • Beer Sheva, Israel, 85025
        • Soroka Medical Center
      • Haifa, Israel, 3104802
        • Bnai Zion Medical Center
      • Haifa, Israel, 3109601
        • Rambam Health Corp
      • Jerusalem, Israel, 91120
        • Hadassah-Hebrew University Medical Center
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
      • Tel Aviv, Israel, 64239
        • Tel-Aviv Sourasky Medical Center
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Retinal Consultants of Arizona
      • Tucson, Arizona, United States, 85704
        • Retina Centers, PC
    • California
      • Bakersfield, California, United States, 93309
        • California Retina Consultants
      • Beverly Hills, California, United States, 90211
        • Retina-Vitreous Associates Medical Group
      • Los Angeles, California, United States, 90033
        • USC Eye Institute
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates Medical Group, Inc.
      • Santa Ana, California, United States, 92705
        • Orange County Retina Medical Group
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Golden, Colorado, United States, 80401
        • Colorado Retina Associates
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Retina Group of Florida
      • Lakeland, Florida, United States, 33805
        • Center for Retina and Macular Disease
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Eye Center Emory University
      • Marietta, Georgia, United States, 30060
        • Marietta Eye Clinic
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Oak Park, Illinois, United States, 60304
        • Illinois Retina Associates, S.C.
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Midwest Eye Retina Practicing at Midwest Eye Institute
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Elman Retina Group, PA
      • Chevy Chase, Maryland, United States, 20815
        • The Retina Group of Washington
    • Massachusetts
      • Ayer, Massachusetts, United States, 01432
        • Valley Eye Physicians and Surgeons, PC
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
      • Waltham, Massachusetts, United States, 01741
        • Ocular Immunology and Uveitis Foundation; Massachusetts Eye Research and Surgery Institution
    • Missouri
      • Independence, Missouri, United States, 64055
        • Discover Vision Centers
    • New Jersey
      • Palisades Park, New Jersey, United States, 07650
        • Metropolitan Eye Research & Surgery Institute
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
      • Slingerlands, New York, United States, 12159
        • Retina Consultants PLLC
    • North Carolina
      • Belmont, North Carolina, United States, 28012
        • Charlotte Eye Ear Nose and Throat Associates, PA
      • Winston-Salem, North Carolina, United States, 27103
        • Wake Forest Baptist Health Eye Center
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Bergstrom Eye Research
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University Casey Eye Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Mid Atlantic Retina
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center Eye Center
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Innovative Clinical Research
    • Texas
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates
      • Houston, Texas, United States, 77030
        • Retina Consultants of Houston
      • San Antonio, Texas, United States, 78233
        • Foresight Studies, LLC
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Houston
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Eye Consultants
    • Washington
      • Bellevue, Washington, United States, 98004
        • Vitreoretinal Associates of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • Triamcinolone Acetonide
SHAM_COMPARATOR: Sham Procedure
Matching suprachoroidal syringe with sham procedure
Drug: Sham Procedure
Sham procedure administered at 2 timepoints
Other Names:
  • suprachoroidal sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks
Time Frame: Baseline, 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.
Baseline, 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Central Subfield Thickness
Time Frame: Baseline, 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.
Baseline, 24 weeks
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline to 24 weeks
Number of subjects with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) reported between the first dose of study drug and study exit.
Baseline to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clearside Biomedical, Inc.

Investigators

  • Study Director: Thomas Cuilla, MD, MBA, Clearside Biomedical, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 17, 2015

Primary Completion (ACTUAL)

January 18, 2018

Study Completion (ACTUAL)

January 18, 2018

Study Registration Dates

First Submitted

October 28, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (ESTIMATE)

November 3, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 28, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLS1001-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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