NCT02396316
Completed
Phase 3
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
ConditionsGlaucoma, Neovascular
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
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.
Investigators
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)
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