A Randomized, Double-masked, and Controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravitreal Administration of Aflibercept in Japanese Patients With Neovascular Glaucoma

Bayer0 sites54 target enrollmentApril 2, 2015

ConditionsGlaucoma, Neovascular

InterventionsAflibercept (Eylea, BAY 86-5321)Sham Injection

DrugsAflibercept (Eylea, BAY 86-5321)Sham Injection

Overview

Phase: Phase 3
Intervention: Aflibercept (Eylea, BAY 86-5321)
Conditions: Glaucoma, Neovascular
Sponsor: Bayer
Enrollment: 54
Primary Endpoint: Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 2, 2015

End Date

September 6, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

Aflibercept

Aflibercept 2 mg Intravitreal (IVT) injection group

Intervention: Aflibercept (Eylea, BAY 86-5321)

Sham Injection

Sham injection group

Intervention: Sham Injection

Outcomes

Primary Outcomes

Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1

Time Frame: From baseline to pre-dose at Week 1

It compared the change in IOP from baseline to pre-dose at Week 1 between the aflibercept group vs the sham group.

Secondary Outcomes

Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1(From baseline to pre-dose at Week 1)