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)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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).
Enrollment
Sex
Ages
Volunteers
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 design
Primary purpose
Allocation
Interventional model
Masking
16 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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