NCT02698566

A Study in Patients With Neovascular Age Related Macular Degeneration or Macular Edema Secondary To Retinal Vein Occlusion to Evaluate Usability of the Ranibizumab (Lucentis®) Prefilled Syringe (PFS)

An Open-Label, Single-Arm Phase IIIb Study in Patients With Neovascular Age-Related Macular Degeneration or Macular Edema Secondary to Retinal Vein Occlusion to Evaluate the Usability of Lucentis® 0.5 mg Prefilled Syringe

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter study designed to evaluate usability of ranibizumab PFS in patients with neovascular age related macular degeneration or macular edema secondary to retinal vein occlusion.

Detailed description

The purpose of this study is to assess the ability of HCPs to follow the instructions for use (IFU) to prepare and administer a ranibizumab PFS ITV injection dose to patients.

Conditions

• Macular Edema

Interventions

Type	Name	Description
DRUG	Ranibizumab	Patients will receive single ITV injection of ranibizumab 0.5 mg delivered via PFS on Day 1.

Timeline

• Start date: 2016-03-21
• Primary completion: 2016-04-05
• Completion: 2016-04-05
• First posted: 2016-03-03
• Last updated: 2017-09-21
• Results posted: 2017-07-26

Locations

4 sites across 1 country: United States