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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)

Primary Purpose

Glaucoma, Neovascular

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Aflibercept (EYLEA, BAY86-5321)
Topical IOP-lowering drugs
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Neovascular

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Fukui Hospital
  • Tsukazaki Hospital
  • Kanazawa University Hospital
  • St. Marianna University School of Medicine Hospital
  • Osaka University Hospital
  • Takatsuki Red Cross Hospital
  • Shimane University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NVG patients

Arm Description

Japanese patients with neovascular glaucoma

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
August 17, 2018
Last Updated
February 18, 2020
Sponsor
Bayer
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03639675
Brief Title
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
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 3, 2018 (Actual)
Primary Completion Date
February 14, 2019 (Actual)
Study Completion Date
March 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Regeneron Pharmaceuticals

4. Oversight

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
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Neovascular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NVG patients
Arm Type
Experimental
Arm Description
Japanese patients with neovascular glaucoma
Intervention Type
Drug
Intervention Name(s)
Aflibercept (EYLEA, BAY86-5321)
Intervention Description
2 mg (0.05 mL), Intravitreal injection (IVT), single dose.
Intervention Type
Drug
Intervention Name(s)
Topical IOP-lowering drugs
Intervention Description
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 Outcome Measure Information:
Title
Change in Intraocular Pressure (IOP) From Baseline to Week 1
Description
The primary efficacy analysis was on the changes in IOP from baseline to Week 1 (LOCF).
Time Frame
Baseline and week 1
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Week 1
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Fukui Hospital
City
Yoshida
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
Tsukazaki Hospital
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
671-1227
Country
Japan
Facility Name
Kanazawa University Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
St. Marianna University School of Medicine Hospital
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Takatsuki Red Cross Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-1096
Country
Japan
Facility Name
Shimane University Hospital
City
Izumo
State/Province
Shimane
ZIP/Postal Code
693-8501
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
33330959
Citation
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.
Results Reference
derived
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer Healthcare products.

Learn more about this trial

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

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