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

August 17, 2017 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Gifu, Japan, 501-1194
      • Kyoto, Japan, 602-0841
      • Osaka, Japan, 545-8586
    • Fukui
      • Yoshida, Fukui, Japan, 910-1193
    • Hyogo
      • Amagasaki, Hyogo, Japan, 660-8550
      • Himeji, Hyogo, Japan, 671-1227
      • Kobe, Hyogo, Japan, 650-0017
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8641
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
    • Oita
      • Yufu, Oita, Japan, 879-5593
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
      • Suita, Osaka, Japan, 565-0871
      • Takatsuki, Osaka, Japan, 569-8686
    • Shimane
      • Izumo, Shimane, Japan, 693-8501
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8655
      • Mitaka, Tokyo, Japan, 181-8611
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-8505
    • Yamanashi
      • Chuo, Yamanashi, Japan, 409-3898

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aflibercept
Aflibercept 2 mg Intravitreal (IVT) injection group
Drug: Aflibercept (Eylea, BAY 86-5321)
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.
Sham Comparator: Sham Injection
Sham injection group
Drug: Sham Injection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1
Time Frame: 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.
From baseline to pre-dose at Week 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1
Time Frame: 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.
From baseline to pre-dose at Week 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2015

Primary Completion (Actual)

June 16, 2016

Study Completion (Actual)

September 6, 2016

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Actual)

September 15, 2017

Last Update Submitted That Met QC Criteria

August 17, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17584

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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