Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients (VEGA)

Bayer

Status and phase: Completed; Phase 3

Conditions: Glaucoma, Neovascular

Treatments: Drug: Aflibercept (Eylea, BAY 86-5321); Drug: Sham Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT02396316

17584

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 2 patient groups

Aflibercept

Experimental group

Description:

Aflibercept 2 mg Intravitreal (IVT) injection group

Treatment:

Drug: Aflibercept (Eylea, BAY 86-5321)

Sham Injection

Sham Comparator group

Description:

Sham injection group

Treatment:

Drug: Sham Injection