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

Phase 3

Completed

• Conditions: Glaucoma, Neovascular
• Interventions: Drug: Aflibercept (EYLEA, BAY86-5321); Drug: Topical IOP-lowering drugs

• Registration Number: NCT03639675
• Lead Sponsor: Bayer

Brief 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-17
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-21
• Study Start: 2018-10-03
• Primary Completion: 2019-02-14
• Study Completion: 2019-03-14
• Status Verified: 2020-02
• Results First Submitted: 2020-02-05
• Results First Submitted QC: 2020-02-05
• Results First Posted: 2020-02-18
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NVG patients	Aflibercept (EYLEA, BAY86-5321)	Japanese patients with neovascular glaucoma
NVG patients	Topical IOP-lowering drugs	Japanese patients with neovascular glaucoma

Primary Outcome Measures

Name	Time	Method
Change in Intraocular Pressure (IOP) From Baseline to Week 1	Baseline and week 1	The primary efficacy analysis was on the changes in IOP from baseline to Week 1 (LOCF).

Secondary Outcome Measures

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

Trial Locations

Locations (7)

University of Fukui Hospital; 🇯🇵 Yoshida, Fukui, Japan

Kanazawa University Hospital; 🇯🇵 Kanazawa, Ishikawa, Japan

Shimane University Hospital; 🇯🇵 Izumo, Shimane, Japan

Tsukazaki Hospital; 🇯🇵 Himeji, Hyogo, Japan

St. Marianna University School of Medicine Hospital; 🇯🇵 Kawasaki, Kanagawa, Japan

Takatsuki Red Cross Hospital; 🇯🇵 Takatsuki, Osaka, Japan

Osaka University Hospital; 🇯🇵 Suita, Osaka, Japan