At a glance
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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)
In Brief
A Phase 3 clinical trial evaluating Aflibercept (EYLEA, BAY86-5321) and Topical IOP-lowering drugs for Glaucoma, Neovascular. Completed, enrolled 16 participants across 7 sites.
Detailed 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).
Study Details
Timeline
Interventions
2 mg (0.05 mL), Intravitreal injection (IVT), single dose.
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