Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02396316
Recruitment Status : Completed
First Posted : March 24, 2015
Results First Posted : July 21, 2017
Last Update Posted : September 15, 2017
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Glaucoma, Neovascular Drug: Aflibercept (Eylea, BAY 86-5321) Drug: Sham Injection Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 2, 2015
Actual Primary Completion Date : June 16, 2016
Actual Study Completion Date : September 6, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02396316


Locations
Layout table for location information
Japan
Yoshida, Fukui, Japan, 910-1193
Amagasaki, Hyogo, Japan, 660-8550
Himeji, Hyogo, Japan, 671-1227
Kobe, Hyogo, Japan, 650-0017
Kanazawa, Ishikawa, Japan, 920-8641
Kawasaki, Kanagawa, Japan, 216-8511
Sendai, Miyagi, Japan, 980-8574
Yufu, Oita, Japan, 879-5593
Hirakata, Osaka, Japan, 573-1191
Suita, Osaka, Japan, 565-0871
Takatsuki, Osaka, Japan, 569-8686
Izumo, Shimane, Japan, 693-8501
Bunkyo-ku, Tokyo, Japan, 113-8655
Mitaka, Tokyo, Japan, 181-8611
Ube, Yamaguchi, Japan, 755-8505
Chuo, Yamanashi, Japan, 409-3898
Gifu, Japan, 501-1194
Kyoto, Japan, 602-0841
Osaka, Japan, 545-8586
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Bayer Study Director Bayer
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02396316    
Other Study ID Numbers: 17584
First Posted: March 24, 2015    Key Record Dates
Results First Posted: July 21, 2017
Last Update Posted: September 15, 2017
Last Verified: August 2017

Layout table for additional information
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:
Layout table for 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