NCT02303184

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Clearside Biomedical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Macular Edema
• Retinal Vein Occlusion

Interventions

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

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-11-27
• Last updated: 2021-02-08
• Results posted: 2021-02-08

Locations

14 sites across 1 country: United States