Trial Condition(s):

Glaucoma, Neovascular

Japanese phase 3 study of Aflibercept in Neovascular glaucoma patients (VEGA)

Bayer Identifier:

17584

ClinicalTrials.gov Identifier:

NCT02396316

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
54
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Kanazawa, Japan, 920-8641

Status
Completed
 
Locations

Investigative Site

Yoshida, Japan, 910-1193

Status
Completed
 
Locations

Investigative Site

Kyoto, Japan, 602-0841

Status
Completed
 
Locations

Investigative Site

Suita, Japan, 565-0871

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 545-8586

Status
Terminated
 
Locations

Investigative Site

Takatsuki, Japan, 569-8686

Status
Completed
 
Locations

Investigative Site

Hirakata, Japan, 573-1191

Status
Completed
 
Locations

Investigative Site

Yufu, Japan, 879-5593

Status
Completed
 
Locations

Investigative Site

Mitaka, Japan, 181-8611

Status
Completed
 
Locations

Investigative Site

Izumo, Japan, 693-8501

Status
Completed
 
Locations

Investigative Site

Ube, Japan, 755-8505

Status
Completed
 
Locations

Investigative Site

Sendai, Japan, 980-8574

Status
Completed
 
Locations

Investigative Site

Bunkyo-ku, Japan, 113-8655

Status
Completed
 
Locations

Investigative Site

Chuo, Japan, 409-3898

Status
Completed
 
Locations

Investigative Site

Gifu, Japan, 501-1194

Status
Terminated
 
Locations

Investigative Site

Kawasaki, Japan, 216-8511

Status
Completed
 
Locations

Investigative Site

Kobe, Japan, 650-0017

Status
Completed
 
Locations

Investigative Site

Himeji, Japan, 671-1227

Status
Completed
 
Locations

Investigative Site

Amagasaki, Japan, 660-8550

Status
Completed
 

Trial Design