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

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
325

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Australia
    • 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)
  • Hungary
      • Budapest, Hungary, 1062
        • MH EK Honvédkorház
  • India
    • 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.
  • New Zealand
      • Auckland, New Zealand, 1050
        • Auckland Eye
  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Drug: suprachoroidal CLS-TA
suprachoroidal injection of CLS-TA
Other Names:
  • Triamcinolone acetonide
Drug: Lucentis or Avastin
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
Drug: Lucentis or Avastin
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
Drug: suprachoroidal sham
sham suprachoroidal procedure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clearside Biomedical, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 18, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLS1003-302

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.

Clinical Trials on Macular Edema

Clinical Trials on suprachoroidal CLS-TA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings