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NCT02303184 Clinical Trial

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

Macular Edema Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02303184
Other study ID # CLS1003-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2015
Est. completion date March 2016

Study information
Verified date January 2021
Source Clearside Biomedical, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• 4 mg CLS-TA
40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
• Sham
suprachoroidal sham procedure
• IVT aflibercept
2 mg intravitreal injection of aflibercept

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Clearside Biomedical, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm 3 months
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