NCT03203447

Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO

A Randomized, Masked, Controlled Trial To Study The Safety And Efficacy Of Suprachoroidal CLS-TA In Combination With An Intravitreal Anti-VEGF Agent In Subjects With Retinal Vein Occlusion

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 325 (actual)
• Sponsor: Clearside Biomedical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 3, multicenter, randomized, masked, controlled, parallel group study is designed to demonstrate that suprachoroidal (SC) CLS-TA administered with intravitreal (IVT) anti-VEGF agent in subjects with treatment naive RVO is superior to IVT anti-VEGF agent used alone.

Detailed description

A Randomized, Masked, Controlled Trial to Study the Safety and Efficacy of Suprachoroidal CLS-TA With Intravitreal Anti-VEGF Agent 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	sham suprachoroidal procedure
DRUG	Lucentis or Avastin	IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin

Timeline

• Start date: 2018-03-05
• Primary completion: 2018-12-18
• Completion: 2018-12-18
• First posted: 2017-06-29
• Last updated: 2021-04-23
• Results posted: 2021-04-23

Locations

92 sites across 5 countries: United States, Australia, Hungary, India, New Zealand

Regulatory

• FDA-regulated drug study