Clinical Trials/NCT02303184

NCT02303184

Completed

Phase 2

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

Clearside Biomedical, Inc.0 sites46 target enrollmentJanuary 2015

ConditionsMacular Edema Retinal Vein Occlusion

Interventions4 mg CLS-TA IVT aflibercept Sham

Drugs4 mg CLS-TA Sham IVT aflibercept

Overview

Phase: Phase 2
Intervention: 4 mg CLS-TA
Conditions: Macular Edema
Sponsor: Clearside Biomedical, Inc.
Enrollment: 46
Primary Endpoint: Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

March 2016

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Clearside Biomedical, Inc.

Responsible Party

Sponsor

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

Arms & Interventions

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

Intervention: 4 mg CLS-TA

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

Intervention: IVT aflibercept

sham + IVT aflibercept

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

Intervention: Sham

sham + IVT aflibercept

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

Intervention: IVT aflibercept

Outcomes

Primary Outcomes

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

Time Frame: 3 months

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