NCT03639675

Study to Learn How the Drug Aflibercept Works in in Japanese Patients With Increased Eye Pressure That is Caused by New Blood Vessels Growing in the Eye (Neovascular Glaucoma or NVG). Safety of the Drug and Patients' Tolerability of the Drug Injection is Also Studied

A Single-arm, Non-randomized and Open-label Phase 3 Study Evaluating the Efficacy, Safety and Tolerability of Intravitreal Aflibercept in Japanese Patients With Neovascular Glaucoma (NVG)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The researchers in this trial want to learn how the drug aflibercept works in in Japanese patients with increased eye pressure that is caused by new blood vessels growing in the eye (neovascular glaucoma or NVG). They also want to find out how patient tolerate the application of the drug that is injected in the vitreous humor of the eye and if this will cause any medical problems during the trial (vitreous humor, also called vitreous body is the clear gel that fills the space between the lens and the retina of the eyeball).

Conditions

• Glaucoma, Neovascular

Interventions

Type	Name	Description
DRUG	Aflibercept (EYLEA, BAY86-5321)	2 mg (0.05 mL), Intravitreal injection (IVT), single dose.
DRUG	Topical IOP-lowering drugs	A combination of at least 3 topical IOP-lowering drugs will be administered during a run-in phase before treatment and should be kept unchanged until IOP evaluation at Week 1, after which they may be reduced according to the investigator's opinion

Timeline

• Start date: 2018-10-03
• Primary completion: 2019-02-14
• Completion: 2019-03-14
• First posted: 2018-08-21
• Last updated: 2020-03-03
• Results posted: 2020-02-18

Locations

7 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study