Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients

Glaucoma, Neovascular Clinical Trial

— VEGA  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02396316
• Other study ID #: 17584
• Status: Completed
• Phase: Phase 3
• First received: March 18, 2015
• Last updated: September 9, 2016
• Start date: April 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Neovascular

Intervention

Drug:
• Aflibercept (Eylea, BAY 86-5321)
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Intraocular pressure (IOP) from baseline to pre-dose at Week 1		Baseline and Week 1	No
Secondary	Proportions of subjects who have improved Neovascularization of the iris (NVI) grade from baseline to Week 1	A subject who shows the improvement by at least one grade is considered to be improved.	Baseline and Week 1	No

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