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Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients (VEGA)

Primary Purpose

Glaucoma, Neovascular

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Aflibercept (Eylea, BAY 86-5321)
Sham Injection
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 Neovascular glaucoma (NVG) with neovascularization in the anterior segment (both iris and anterior chamber angle),
  • Patients with Intraocular pressure (IOP) 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 Neovascular glaucoma
  • 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Aflibercept

Sham Injection

Arm Description

Aflibercept 2 mg Intravitreal (IVT) injection group

Sham injection group

Outcomes

Primary Outcome Measures

Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1
It compared the change in IOP from baseline to pre-dose at Week 1 between the aflibercept group vs the sham group.

Secondary Outcome Measures

Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1
NVI were assessed in the study eye using the NVI grading systems (grade 0 to grade 4). A subject who shows the improvement by at least one grade is considered to be improved. Percentage of subjects who had improved NVI grade was reported.

Full Information

First Posted
March 18, 2015
Last Updated
August 17, 2017
Sponsor
Bayer
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02396316
Brief Title
Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients
Acronym
VEGA
Official Title
A Randomized, Double-masked, and Controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravitreal Administration of Aflibercept in Japanese Patients With Neovascular Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2, 2015 (Actual)
Primary Completion Date
June 16, 2016 (Actual)
Study Completion Date
September 6, 2016 (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
To assess the efficacy and safety of the administration of aflibercept by intravitreal injection in comparison to sham to control intraocular pressure in patients with neovascular glaucoma.

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
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aflibercept
Arm Type
Experimental
Arm Description
Aflibercept 2 mg Intravitreal (IVT) injection group
Arm Title
Sham Injection
Arm Type
Sham Comparator
Arm Description
Sham injection group
Intervention Type
Drug
Intervention Name(s)
Aflibercept (Eylea, BAY 86-5321)
Intervention Description
After the first aflibercept IVT injection on Day 1, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met.
Intervention Type
Drug
Intervention Name(s)
Sham Injection
Intervention Description
After the first sham injection on Day 1, subjects may receive aflibercept IVT injection at Week 1, Week 5 and/or Week 9 if re-treatment criteria are met.
Primary Outcome Measure Information:
Title
Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1
Description
It compared the change in IOP from baseline to pre-dose at Week 1 between the aflibercept group vs the sham group.
Time Frame
From baseline to pre-dose at Week 1
Secondary Outcome Measure Information:
Title
Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1
Description
NVI were assessed in the study eye using the NVI grading systems (grade 0 to grade 4). A subject who shows the improvement by at least one grade is considered to be improved. Percentage of subjects who had improved NVI grade was reported.
Time Frame
From baseline to pre-dose at 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 Neovascular glaucoma (NVG) with neovascularization in the anterior segment (both iris and anterior chamber angle), Patients with Intraocular pressure (IOP) 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 Neovascular glaucoma 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Yoshida
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
City
Amagasaki
State/Province
Hyogo
ZIP/Postal Code
660-8550
Country
Japan
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
671-1227
Country
Japan
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
City
Yufu
State/Province
Oita
ZIP/Postal Code
879-5593
Country
Japan
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
City
Izumo
State/Province
Shimane
ZIP/Postal Code
693-8501
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
City
Chuo
State/Province
Yamanashi
ZIP/Postal Code
409-3898
Country
Japan
City
Gifu
ZIP/Postal Code
501-1194
Country
Japan
City
Kyoto
ZIP/Postal Code
602-0841
Country
Japan
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
33330958
Citation
Inatani M, Higashide T, Matsushita K, Miki A, Ueki M, Iwamoto Y, Kobayashi M, Leal S; VEGA Investigators. Intravitreal Aflibercept in Japanese Patients with Neovascular Glaucoma: The VEGA Randomized Clinical Trial. Adv Ther. 2021 Feb;38(2):1116-1129. doi: 10.1007/s12325-020-01579-5. Epub 2020 Dec 16.
Results Reference
derived

Learn more about this trial

Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients

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