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

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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Key information

Conditions

Glaucoma, Neovascular Eye Diseases Glaucoma Ocular Hypertension

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Fukui Hospital, Yoshida, Fukui, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

Time frame: Baseline and week 1

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

Secondary outcomes

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

Time frame: Baseline and 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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

Regeneron Pharmaceuticals

Registry information

Official study title

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)

Acronym: VENERA

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Aug 21, 2018
Registry last updated: Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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