Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients

Bayer54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Glaucoma, Neovascular

Interventions

Aflibercept (Eylea, BAY 86-5321)DRUG

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.

Sham InjectionDRUG

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (19)

Unnamed facility

Yoshida, Fukui, Japan

Unnamed facility

Gifu, Gifu, Japan

Unnamed facility

Amagasaki, Hyōgo, Japan

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

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

Data from ClinicalTrials.gov

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