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 (VENERA)

• ClinicalTrials.gov Identifier: NCT03639675
• Recruitment Status: Completed
• First Posted: August 21, 2018
• Results First Posted: February 18, 2020
• Last Update Posted: March 3, 2020
• Sponsor: Bayer
• Collaborator: Regeneron Pharmaceuticals
• Information provided by (Responsible Party): Bayer

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Glaucoma, Neovascular	Drug: Aflibercept (EYLEA, BAY86-5321); Drug: Topical IOP-lowering drugs	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: October 3, 2018
• Actual Primary Completion Date: February 14, 2019
• Actual Study Completion Date: March 14, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: NVG patients; Japanese patients with neovascular glaucoma	Drug: Aflibercept (EYLEA, BAY86-5321); 2 mg (0.05 mL), Intravitreal injection (IVT), single dose.; 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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Japan

University of Fukui Hospital

Yoshida, Fukui, Japan, 910-1193

Tsukazaki Hospital

Himeji, Hyogo, Japan, 671-1227

Kanazawa University Hospital

Kanazawa, Ishikawa, Japan, 920-8641

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, Japan, 216-8511

Osaka University Hospital

Suita, Osaka, Japan, 565-0871

Takatsuki Red Cross Hospital

Takatsuki, Osaka, Japan, 569-1096

Shimane University Hospital

Izumo, Shimane, Japan, 693-8501

Sponsors and Collaborators

Bayer

Regeneron Pharmaceuticals

  Study Documents (Full-Text)

Documents provided by Bayer:

Study Protocol  [PDF] May 18, 2018

Statistical Analysis Plan  [PDF] September 7, 2018

More Information

Additional Information:

Click here to find results for studies related to Bayer Healthcare products. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Inatani M, Higashide T, Matsushita K, Nagasato D, Takagi H, Ueki M, Takai Y, Miyazaki K, Iwamoto Y, Kobayashi M, Leal S. Efficacy and Safety of Intravitreal Aflibercept Injection in Japanese Patients with Neovascular Glaucoma: Outcomes from the VENERA Study. Adv Ther. 2021 Feb;38(2):1106-1115. doi: 10.1007/s12325-020-01580-y. Epub 2020 Dec 16.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT03639675
• Other Study ID Numbers: 19652
• First Posted: August 21, 2018
• Results First Posted: February 18, 2020
• Last Update Posted: March 3, 2020
• Last Verified: February 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Glaucoma; Glaucoma, Neovascular; Ocular Hypertension; Eye Diseases; Aflibercept; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antineoplastic Agents