Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO (TANZANITE)

January 18, 2021 updated by: Clearside Biomedical, Inc.

TANZANITE: Safety and Efficacy of Suprachoroidal CLS-TA in Combination With Intravitreal Aflibercept in Subjects With Macular Edema Following Retinal Vein Occlusion

A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA, triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT) injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein occlusion (RVO).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized, masked, controlled trial of safety and efficacy of suprachoroidal CLS-TA in combination with intravitreal aflibercept in subjects with macular edema following retinal vein occlusion

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
    • California
      • Beverly Hills, California, United States, 90211
      • San Diego, California, United States, 92037
    • Florida
      • Boynton Beach, Florida, United States, 33426
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Maryland
      • Baltimore, Maryland, United States, 21287
    • Missouri
      • Saint Louis, Missouri, United States, 63128
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
    • Texas
      • Abilene, Texas, United States, 79606
      • Houston, Texas, United States, 77030
      • McAllen, Texas, United States, 78503
      • San Antonio, Texas, United States, 78251
      • The Woodlands, Texas, United States, 77384

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 macular edema following RVO
  • History of ME ≤ 12 months
  • 20-70 letters inclusive BCVA using ETDRS

Exclusion Criteria:

  • has had an IVT injection of anti-VEGF for RVO in the study eye
  • has had a corticosteroid injection in the past 3 months in the study eye
  • any uncontrolled ophthalmic condition in the study eye other than RVO

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
Experimental: 4 mg CLS-TA + IVT aflibercept
Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept
Drug: IVT aflibercept
2 mg intravitreal injection of aflibercept
Other Names:
  • Eylea
Drug: 4 mg CLS-TA
40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
Active Comparator: sham + IVT aflibercept
Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept
Drug: IVT aflibercept
2 mg intravitreal injection of aflibercept
Other Names:
  • Eylea
Drug: Sham
suprachoroidal sham procedure
Other Names:
  • suprachoroidal sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Clearside Biomedical, Inc.

Investigators

  • Study Director: Thomas Ciulla, MD, Clearside Biomedical, Inc.

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

January 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

November 25, 2014

First Posted (Estimate)

November 27, 2014

Study Record Updates

Last Update Posted (Actual)

February 8, 2021

Last Update Submitted That Met QC Criteria

January 18, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLS1003-201

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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