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

Conditions

• Glaucoma, Neovascular

Eligibility Criteria

Sex

ALL

Age

20 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Aflibercept (EYLEA, BAY86-5321) — DRUG
  2 mg (0.05 mL), Intravitreal injection (IVT), single dose.
• Topical IOP-lowering drugs — DRUG
  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

Study Details

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).

Key Dates

Start date

Oct 3, 2018

Status verified

Feb 2020

Primary completion

Feb 14, 2019

Completion

Mar 14, 2019

Study Design

Enrollment

16 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: NVG patients
  Japanese patients with neovascular glaucoma

Primary Outcome Measure

Change in Intraocular Pressure (IOP) From Baseline to Week 1 [ Time Frame: Baseline and week 1 ]