Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients

Conditions

• Glaucoma, Neovascular

Eligibility Criteria

Sex

ALL

Age

20 Years - N/A

Healthy Volunteers

Not accepted

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 Injection — DRUG
  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.

Study Details

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.

Key Dates

Start date

Apr 2, 2015

Status verified

Aug 2017

Primary completion

Jun 16, 2016

Completion

Sep 6, 2016

Study Design

Enrollment

54 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Aflibercept
  Aflibercept 2 mg Intravitreal (IVT) injection group
• Sham Comparator: Sham Injection
  Sham injection group

Primary Outcome Measure

Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1 [ Time Frame: From baseline to pre-dose at Week 1 ]