Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients

• Status: Completed
• Trial end date: 2016-09-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Aflibercept

Criteria

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.