NCT02396316

Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients

A Randomized, Double-masked, and Controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravitreal Administration of Aflibercept in Japanese Patients With Neovascular Glaucoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy and safety of the administration of aflibercept by intravitreal injection in comparison to sham to control intraocular pressure in patients with neovascular glaucoma.

Conditions

• Glaucoma, Neovascular

Interventions

Type	Name	Description
DRUG	Aflibercept (Eylea, BAY 86-5321)	After the first aflibercept IVT injection on Day 1, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met.
DRUG	Sham Injection	After the first sham injection on Day 1, subjects may receive aflibercept IVT injection at Week 1, Week 5 and/or Week 9 if re-treatment criteria are met.

Timeline

• Start date: 2015-04-02
• Primary completion: 2016-06-16
• Completion: 2016-09-06
• First posted: 2015-03-24
• Last updated: 2017-09-15
• Results posted: 2017-07-21

Locations

19 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study