Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients
VEGA
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
1 other identifier
interventional
54
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2015
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2015
CompletedFirst Posted
Study publicly available on registry
March 24, 2015
CompletedStudy Start
First participant enrolled
April 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2016
CompletedResults Posted
Study results publicly available
July 21, 2017
CompletedSeptember 15, 2017
August 1, 2017
1.2 years
March 18, 2015
June 15, 2017
August 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
From baseline to pre-dose at Week 1
Secondary Outcomes (1)
Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1
From baseline to pre-dose at Week 1
Study Arms (2)
Aflibercept
EXPERIMENTALAflibercept 2 mg Intravitreal (IVT) injection group
Sham Injection
SHAM COMPARATORSham injection group
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Regeneron Pharmaceuticalscollaborator
Study Sites (19)
Unknown Facility
Yoshida, Fukui, 910-1193, Japan
Unknown Facility
Gifu, Gifu, 501-1194, Japan
Unknown Facility
Amagasaki, Hyōgo, 660-8550, Japan
Unknown Facility
Himeji, Hyōgo, 671-1227, Japan
Unknown Facility
Kobe, Hyōgo, 650-0017, Japan
Unknown Facility
Kanazawa, Ishikawa-ken, 920-8641, Japan
Unknown Facility
Kawasaki, Kanagawa, 216-8511, Japan
Unknown Facility
Sendai, Miyagi, 980-8574, Japan
Unknown Facility
Yufu, Oita Prefecture, 879-5593, Japan
Unknown Facility
Hirakata, Osaka, 573-1191, Japan
Unknown Facility
Suita, Osaka, 565-0871, Japan
Unknown Facility
Takatsuki, Osaka, 569-8686, Japan
Unknown Facility
Izumo, Shimane, 693-8501, Japan
Unknown Facility
Bunkyo-ku, Tokyo, 113-8655, Japan
Unknown Facility
Mitaka, Tokyo, 181-8611, Japan
Unknown Facility
Ube, Yamaguchi, 755-8505, Japan
Unknown Facility
Chūō, Yamanashi, 409-3898, Japan
Unknown Facility
Kyoto, 602-0841, Japan
Unknown Facility
Osaka, 545-8586, Japan
Related Publications (2)
Rittiphairoj T, Roberti G, Michelessi M. Anti-vascular endothelial growth factor for neovascular glaucoma. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD007920. doi: 10.1002/14651858.CD007920.pub4.
PMID: 37010901DERIVEDInatani 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.
PMID: 33330958DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2015
First Posted
March 24, 2015
Study Start
April 2, 2015
Primary Completion
June 16, 2016
Study Completion
September 6, 2016
Last Updated
September 15, 2017
Results First Posted
July 21, 2017
Record last verified: 2017-08