Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO (TOPAZ)

April 22, 2021 updated by: Clearside Biomedical, Inc.

A Randomized, Masked, Controlled Trial To Study The Safety And Efficacy Of Suprachoroidal CLS-TA In Combination With An Intravitreal Anti-VEGF Agent In Subjects With Retinal Vein Occlusion

This Phase 3, multicenter, randomized, masked, controlled, parallel group study is designed to demonstrate that suprachoroidal (SC) CLS-TA administered with intravitreal (IVT) anti-VEGF agent in subjects with treatment naive RVO is superior to IVT anti-VEGF agent used alone.

Study Overview

Detailed Description

A Randomized, Masked, Controlled Trial to Study the Safety and Efficacy of Suprachoroidal CLS-TA With Intravitreal Anti-VEGF Agent in Subjects With Retinal Vein Occlusion

Study Type

Interventional

Enrollment (Actual)

325

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

    • New South Wales
      • Albury, New South Wales, Australia, 2640
        • Eye Clinic Albury Wodonga
      • Strathfield, New South Wales, Australia, 2135
        • Strathfield Retina Clinic
      • Sydney, New South Wales, Australia, 2000
        • Save Sight Institute, University of Sydney (Sydney Eye Hospital)
      • Budapest, Hungary, 1062
        • MH EK Honvédkorház
    • Ahmedabad
      • Gujrat, Ahmedabad, India, 380052
        • Raghudeep Eye Hospital
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500034
        • LV Prasad Eye Institute
      • Visakhapatnam, Andhra Pradesh, India, 530040
        • L V Prasad Eye Institute
    • Ansari Nagar
      • New Delhi, Ansari Nagar, India, 110029
        • R.P. Centre, AIIMS
    • Bangalaore
      • RajajiNagar, Bangalaore, India, 560010
        • Narayana Nethralaya
    • Bhubaneswar
      • Patia, Bhubaneswar, India, 751024
        • LV Prasad Eye Institute
    • Gujarat
      • Asarwa, Gujarat, India, 380016
        • M&J Western Regional Institute of Ophthalmology
    • Maharashtra
      • Pune, Maharashtra, India, 411060
        • PBMA's H.V Desai Eye Hospital
    • New Delhi
      • Delhi, New Delhi, India, 758770
        • Dr Shroff 's Charity Eye Hospital
    • Patna
      • Bihar, Patna, India, 800001
        • Regional Institute of Ophthalmology
    • Raghunathpur
      • Kolkata, Raghunathpur, India, 700059
        • B B Eye Foundation VIP
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • SMS Hospital
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625020
        • Aravind Eye Hospital
    • Uttar Pradesh
      • Kanpur, Uttar Pradesh, India, 208005
        • Jawaharlal Rohatgi Eye Hospital
    • West Bengal
      • Kolkata, West Bengal, India, 700120
        • Disha Eye Hospitals Pvt. Ltd.
      • Auckland, New Zealand, 1050
        • Auckland Eye
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Retinal Research Institute
      • Tucson, Arizona, United States, 85704
        • Retina Centers PC
      • Tucson, Arizona, United States, 85710
        • Retina Associates Southwest PC
    • California
      • Arcadia, California, United States, 91006
        • Win Retina
      • Beverly Hills, California, United States, 90211
        • Retina Vitreous Medical Group
      • Campbell, California, United States, 95008
        • Retinal Diagnostic Center
      • Fullerton, California, United States, 92835
        • Retina Consultants of Orange County
      • Glendale, California, United States, 91203
        • Macula and Retina Institute
      • Los Angeles, California, United States, 90017
        • American Institute of Research
      • Mountain View, California, United States, 94040
        • Retina Vitreous Associates Medical Group Inc
      • Palo Alto, California, United States, 94303
        • Stanford University - Byers Eye Institute
      • Redlands, California, United States, 92374
        • Retina Consultants of Southern California
      • Sacramento, California, United States, 95819
        • Retina Consultants Medical Group Inc
      • Whittier, California, United States, 90603
        • American Institute of Research
    • Connecticut
      • New London, Connecticut, United States, 06320
        • Retina Group of New England, PC
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Florida Eye Microsurgical Institute
      • Coral Springs, Florida, United States, 33067
        • Specialty Retina Center
      • Fort Myers, Florida, United States, 33912
        • National Ophthalmic Research Institute
      • Melbourne, Florida, United States, 32904
        • Center for Retina Care at The Eye Institute
      • Orlando, Florida, United States, 32806
        • Florida Retina Institute
      • Pinellas Park, Florida, United States, 33782
        • Eye Associates of Pinellas
      • Saint Petersburg, Florida, United States, 33711
        • Retina Vitreous Associates of Florida
      • Stuart, Florida, United States, 34994
        • East Florida Eye Institute EFEI
      • Tallahassee, Florida, United States, 32308
        • Southern Vitreoretinal Association
      • Winter Haven, Florida, United States, 33880
        • Center for Retina and Macular Disease
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Retina Consultants of Hawaii
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • Gailey Eye Clinic
      • Oak Forest, Illinois, United States, 60452
        • University and Macula Associates
      • Springfield, Illinois, United States, 62704
        • Prairie Eye Center, Ltd.
    • Kansas
      • Leawood, Kansas, United States, 66211
        • Sabates Eye Centers
      • Wichita, Kansas, United States, 67214
        • Vitreo-Retinal Consultants and Surgeons PA
      • Wichita, Kansas, United States, 67226
        • Central Plains Eye MDs
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Paducah Retinal Center
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • The Retina Care Center
      • Baltimore, Maryland, United States, 21204
        • Retina Specialists
      • Chevy Chase, Maryland, United States, 20815
        • Retina Group of Washington
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants
      • Towson, Maryland, United States, 21204
        • The National Retina Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
      • Springfield, Massachusetts, United States, 01107
        • New England Retina Consultants
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Associated Retinal Consultants PC
      • Grand Rapids, Michigan, United States, 49546
        • Vitreo-Retinal Associates, P.C.
      • Royal Oak, Michigan, United States, 48073
        • Associated Retinal Consultants P.C.
      • Southfield, Michigan, United States, 48034
        • Retina Consultants of Michigan
      • Traverse City, Michigan, United States, 49686
        • Associated Retinal Consultants PC
    • Missouri
      • Florissant, Missouri, United States, 63031
        • Retina Associates of St. Louis
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Retina Consultants of Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New York
      • Lynbrook, New York, United States, 11563
        • Ophthalmic Consultants of Long Island
      • Rochester, New York, United States, 14620
        • Retina Associates of Western New York
      • Shirley, New York, United States, 11967
        • Island Retina
      • Syracuse, New York, United States, 13224
        • Retina-Vitreous Surgeons of Central New York
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Retina Associates of Cleveland Inc
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Dean A. McGee Eye Institute
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Pennsylvania Retina Specialists PC
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Retina Associates - Arlington
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Austin, Texas, United States, 78705
        • Retina Research Center
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates
      • Houston, Texas, United States, 77030
        • Retina Consultants of Houston, PA
      • Houston, Texas, United States, 77025
        • Retina and Vitreous of Texas, PLLC
      • McAllen, Texas, United States, 78503
        • Valley Retina Institute, PA
      • Plano, Texas, United States, 75093
        • Retina Specialists
      • San Antonio, Texas, United States, 78240
        • Medical Center Ophthalmology Associates
      • San Antonio, Texas, United States, 78215
        • San Antonio Eye Center
      • San Antonio, Texas, United States, 78240
        • Retina Associates of South Texas PA
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Houston, PA
      • Willow Park, Texas, United States, 76087
        • Strategic Clinical Research Group, LLC
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Rocky Mountain Retina Consultants
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Retina Group of Washington
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Medicine Eye Institute

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Has a clinical diagnosis of RVO in the study eye
  • Has a CST of ≥ 300 µm in the study eye
  • Has an ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye
  • Is naïve to local pharmacologic treatment for RVO in the study eye

Exclusion Criteria:

  • Any active ocular disease or infection in the study eye other than RVO
  • History of glaucoma, intraocular pressure > 21 mmHg or ocular hypertension requiring more than one medication
  • Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
  • Any evidence of neovascularization in the study eye

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active
Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection
suprachoroidal injection of CLS-TA
Other Names:
  • Triamcinolone acetonide
IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
Other Names:
  • IVT anti-VEGF agent
Sham Comparator: Control
Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure
IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
Other Names:
  • IVT anti-VEGF agent
sham suprachoroidal procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)
Time Frame: 2 months
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 an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Best Corrected Visual Acuity
Time Frame: 6 months
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 an ETDRS eye chart. A positive change from baseline value represents an improvement in vision.
6 months
Mean Change From Baseline in Central Subfield Thickness
Time Frame: 6 months
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.
6 months

Collaborators and Investigators

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

Investigators

  • Study Director: Thomas Ciulla, MD, Chief Medical Officer

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)

March 5, 2018

Primary Completion (Actual)

December 18, 2018

Study Completion (Actual)

December 18, 2018

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

June 28, 2017

First Posted (Actual)

June 29, 2017

Study Record Updates

Last Update Posted (Actual)

April 23, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

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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