Skip to main content
OpenTrials
Completed

NCT Number: NCT02396316

Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glaucoma, Neovascular Eye Diseases Glaucoma Ocular Hypertension

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yoshida, Fukui, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

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

Acronym: VEGA

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 24, 2015
Registry last updated
Sep 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.