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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-03

Study Completion Date

2019-03-14

Brief Summary

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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).

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Detailed Description

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Conditions

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Glaucoma, Neovascular

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NVG patients

Japanese patients with neovascular glaucoma

Group Type EXPERIMENTAL

Aflibercept (EYLEA, BAY86-5321)

Intervention Type DRUG

2 mg (0.05 mL), Intravitreal injection (IVT), single dose.

Topical IOP-lowering drugs

Intervention Type 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

Interventions

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Aflibercept (EYLEA, BAY86-5321)

2 mg (0.05 mL), Intravitreal injection (IVT), single dose.

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Japanese men and women aged 20 years or older
* Patients diagnosed as having NVG (neovascular glaucoma) with neovascularization in the anterior segment (both iris and anterior chamber angle)
* Patients with IOP (intraocular pressure) higher than 25 mmHg in the study eye due to anterior segment (both iris and anterior chamber angle) neovascularization

Exclusion Criteria

* Patients with angle-closure due to conditions other than NVG or complete angle-closure due to NVG
* Patients with a known or suspected ocular or peri-ocular infection
* Patients with severe intraocular inflammation in the study eye
* Women who are pregnant, suspected of being pregnant or lactating
* Patients with known allergy to aflibercept

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No