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
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)
1 other identifier
interventional
16
1 country
7
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).
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 Oct 2018
Shorter than P25 for phase_3
7 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
August 17, 2018
CompletedFirst Posted
Study publicly available on registry
August 21, 2018
CompletedStudy Start
First participant enrolled
October 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2019
CompletedResults Posted
Study results publicly available
February 18, 2020
CompletedMarch 3, 2020
February 1, 2020
4 months
August 17, 2018
February 5, 2020
February 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Baseline and week 1
Secondary Outcomes (1)
Percentage of Participants Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Week 1
Baseline and week 1
Study Arms (1)
NVG patients
EXPERIMENTALJapanese patients with neovascular glaucoma
Interventions
2 mg (0.05 mL), Intravitreal injection (IVT), single dose.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Regeneron Pharmaceuticalscollaborator
Study Sites (7)
University of Fukui Hospital
Yoshida, Fukui, 910-1193, Japan
Tsukazaki Hospital
Himeji, Hyōgo, 671-1227, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, 216-8511, Japan
Osaka University Hospital
Suita, Osaka, 565-0871, Japan
Takatsuki Red Cross Hospital
Takatsuki, Osaka, 569-1096, Japan
Shimane University Hospital
Izumo, Shimane, 693-8501, Japan
Related Publications (1)
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.
PMID: 33330959DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2018
First Posted
August 21, 2018
Study Start
October 3, 2018
Primary Completion
February 14, 2019
Study Completion
March 14, 2019
Last Updated
March 3, 2020
Results First Posted
February 18, 2020
Record last verified: 2020-02