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

Primary Purpose

Macular Edema, Retinal Vein Occlusion

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
4 mg CLS-TA
Sham
IVT aflibercept
Sponsored by
Clearside Biomedical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema focused on measuring RVO, ME, Central Subfield Thickness, OCT, optical coherence tomography, cystoid macular edema, subretinal fluid, Eylea, aflibercept, anti-VEGF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

4 mg CLS-TA + IVT aflibercept

sham + IVT aflibercept

Arm Description

Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept

Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept

Outcomes

Primary Outcome Measures

Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm

Secondary Outcome Measures

Full Information

First Posted
November 25, 2014
Last Updated
January 18, 2021
Sponsor
Clearside Biomedical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02303184
Brief Title
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO
Acronym
TANZANITE
Official Title
TANZANITE: Safety and Efficacy of Suprachoroidal CLS-TA in Combination With Intravitreal Aflibercept in Subjects With Macular Edema Following Retinal Vein Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clearside Biomedical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Retinal Vein Occlusion
Keywords
RVO, ME, Central Subfield Thickness, OCT, optical coherence tomography, cystoid macular edema, subretinal fluid, Eylea, aflibercept, anti-VEGF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4 mg CLS-TA + IVT aflibercept
Arm Type
Experimental
Arm Description
Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept
Arm Title
sham + IVT aflibercept
Arm Type
Active Comparator
Arm Description
Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept
Intervention Type
Drug
Intervention Name(s)
4 mg CLS-TA
Intervention Description
40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
Intervention Type
Drug
Intervention Name(s)
Sham
Other Intervention Name(s)
suprachoroidal sham
Intervention Description
suprachoroidal sham procedure
Intervention Type
Drug
Intervention Name(s)
IVT aflibercept
Other Intervention Name(s)
Eylea
Intervention Description
2 mg intravitreal injection of aflibercept
Primary Outcome Measure Information:
Title
Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Ciulla, MD
Organizational Affiliation
Clearside Biomedical, Inc.
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78251
Country
United States
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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