Trial Condition(s):

Glaucoma, Neovascular

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)

Bayer Identifier:

19652

ClinicalTrials.gov Identifier:

NCT03639675

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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).

Inclusion Criteria
- 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
Exclusion Criteria
- 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

Trial Summary

Enrollment Goal
16
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

University of Fukui Hospital

Yoshida, Japan, 910-1193

Status
Completed
 
Locations

Tsukazaki Hospital

Himeji, Japan, 671-1227

Status
Completed
 
Locations

Osaka University Hospital

Suita, Japan, 565-0871

Status
Completed
 
Locations

Takatsuki Red Cross Hospital

Takatsuki, Japan, 569-1096

Status
Completed
 
Locations

St. Marianna University School of Medicine Hospital

Kawasaki, Japan, 216-8511

Status
Completed
 
Locations

Kanazawa University Hospital

Kanazawa, Japan, 920-8641

Status
Completed
 
Locations

Shimane University Hospital

Izumo, Japan, 693-8501

Status
Completed
 

Trial Design