NCT02980874

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

SAPPHIRE: A Randomized, Masked, Controlled Trial To Study The Safety And Efficacy Of Suprachoroidal CLS-TA In Conjunction With Intravitreal Aflibercept In Subjects With Retinal Vein Occlusion

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 460 (actual)
• Sponsor: Clearside Biomedical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO.

Detailed description

A randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in conjunction with intravitreal aflibercept in subjects with retinal vein occlusion

Conditions

• Macular Edema
• Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	suprachoroidal CLS-TA	suprachoroidal injection of CLS-TA
DRUG	suprachoroidal sham	suprachoroidal sham procedure
DRUG	IVT aflibercept	2 mg intravitreal injection of aflibercept

Timeline

• Start date: 2017-01-31
• Primary completion: 2018-12-10
• Completion: 2018-12-10
• First posted: 2016-12-02
• Last updated: 2021-04-14
• Results posted: 2021-04-14

Locations

110 sites across 16 countries: United States, Australia, Austria, Canada, Denmark, Hungary, India, Israel, Italy, Philippines, Poland, Portugal, Slovakia, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study