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

Bayer16 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma, Neovascular

Interventions

Aflibercept (EYLEA, BAY86-5321)

Topical IOP-lowering drugsDRUG

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (7)

University of Fukui Hospital

Yoshida, Fukui, Japan

Tsukazaki Hospital

Himeji, Hyōgo, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, Japan

Osaka University Hospital

Suita, Osaka, Japan

Takatsuki Red Cross Hospital

Takatsuki, Osaka, Japan

Shimane University Hospital

Izumo, Shimane, Japan

Outcomes

Primary Outcomes

Change in Intraocular Pressure (IOP) From Baseline to Week 1

The primary efficacy analysis was on the changes in IOP from baseline to Week 1 (LOCF).

Time frame: Baseline and week 1

Secondary Outcomes

Percentage of Participants Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Week 1

NVI Grade: 0=No iris neovascularization; 1=Fine surface neovascularization of the pupillary zone of the iris involving less than two quadrants; 2=Surface neovascularization of the pupillary zone of the iris involving more than two quadrants; 3=In addition to neovascularization of the pupillary zone, neovascularization of the ciliary zone of the iris and/or ectropion uveae involving one to three quadrants; 4=In addition to neovascularization of the pupillary zone, neovascularization of the ciliary zone of the iris and/or ectropion uveae involving more than three quadrants. The change in NVI grades categorized to "Improved" means improvement by at least one grade from baseline.

Time frame: Baseline and week 1