Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Glaucoma, Neovascular

Intervention / Treatment
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* Drug: Aflibercept (Eylea, BAY 86-5321)
* Drug: Sham Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aflibercept<br>Aflibercept 2 mg Intravitreal (IVT) injection group | Drug: Aflibercept (Eylea, BAY 86-5321)<br>* After the first aflibercept IVT injection on Day 1, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met.<br>|
| Sham Comparator: Sham Injection<br>Sham injection group | Drug: Sham Injection<br>* After the first sham injection on Day 1, subjects may receive aflibercept IVT injection at Week 1, Week 5 and/or Week 9 if re-treatment criteria are met.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intraocular Pressure (IOP) 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. | From baseline to pre-dose at Week 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade 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. | From baseline to pre-dose at Week 1 |