Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients

Phase 3

Completed

• Conditions: Glaucoma, Neovascular
• Interventions: Drug: Aflibercept (Eylea, BAY 86-5321); Drug: Sham Injection

• Registration Number: NCT02396316
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-03-18
• Study First Posted: 2015-03-24
• Study Start: 2015-04-02
• Primary Completion: 2016-06-16
• Study Completion: 2016-09-06
• Results First Submitted: 2017-06-15
• Results First Submitted QC: 2017-06-15
• Results First Posted: 2017-07-21
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aflibercept	Aflibercept (Eylea, BAY 86-5321)	Aflibercept 2 mg Intravitreal (IVT) injection group
Sham Injection	Sham Injection	Sham injection group

Primary Outcome Measures

Name	Time	Method
Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1	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 Outcome Measures

Name	Time	Method
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	NVI were assessed in the study eye using the NVI grading systems (grade 0 to grade 4). A subject who shows the improvement by at least one grade is considered to be improved. Percentage of subjects who had improved NVI grade was reported.