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

Glaucoma, Neovascular Clinical Trial

— VENERA  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03639675
• Other study ID #: 19652
• Status: Completed
• Phase: Phase 3
• Start date: October 3, 2018
• Est. completion date: March 14, 2019

Study information

• Verified date: February 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 14, 2019
• Est. primary completion date: February 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Neovascular

Intervention

Drug:
• Aflibercept (EYLEA, BAY86-5321)
2 mg (0.05 mL), Intravitreal injection (IVT), single dose.
• 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

Locations

Country	Name	City	State
Japan	Tsukazaki Hospital	Himeji	Hyogo
Japan	Shimane University Hospital	Izumo	Shimane
Japan	Kanazawa University Hospital	Kanazawa	Ishikawa
Japan	St. Marianna University School of Medicine Hospital	Kawasaki	Kanagawa
Japan	Osaka University Hospital	Suita	Osaka
Japan	Takatsuki Red Cross Hospital	Takatsuki	Osaka
Japan	University of Fukui Hospital	Yoshida	Fukui

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and week 1
Secondary	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.	Baseline and week 1

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