Intraocular Pressure Change Following Intravitreal Injection of Anti-vascular Endothelial Growth Factor Agent

Completed

• Conditions: Intraocular Pressure

• Registration Number: NCT02474225
• Lead Sponsor: Prince of Songkla University

Brief Summary

The introduction of additional fluid into the vitreous cavity by intravitreal therapy would be expected to cause an immediate rise in the intraocular pressure. This transient, short-term intraocular pressure elevation (lasting up to 30 minutes) after intravitreal anti-vascular endothelial growth factor therapy has been well describe. The investigators aim to study the prevalence of the sustained intraocular pressure elevation associated with intravitreal injection of anti-vascular endothelial growth factor agents.

Detailed Description

Intravitreal injections of anti-vascular endothelial growth factor agents are commonly used to treat a variety of retinal and choroidal neovascular diseases. The introduction of additional fluid into the vitreous cavity by intravitreal therapy would be expected to cause an immediate rise in the intraocular pressure.

Although there is one study showed no significant changes in the intraocular pressure many retrospective studies showed the impacts on the intraocular pressure elevation. The investigators aim to prospective evaluate the intraocular pressure change in non-glaucomatous patients receiving an intravitreal anti-vascular endothelial growth factor therapy.

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-06
• Study First Submitted: 2015-06-11
• Study First Submitted QC: 2015-06-16
• Last Update Submitted: 2015-06-16
• Study First Posted: 2015-06-17
• Last Update Posted: 2015-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients scheduled to receive intravitreal injection of anti-vascular endothelial growth factor agent (either bevacizumab or ranibizumab), and
• Age of 18-85 year-old, and
• Initial intraocular pressure < 21 mmHg

Exclusion Criteria

• Diagnosis of open angle, or
• Diagnosis of angle-closure glaucoma, or
• Diagnosis of glaucoma suspect (intraocular pressure > 21 mmHg on 2-consecutive visit and/or cup to disc ratio > 0.5) , or
• Currently receive systemic beta-blocker
• Previously received intravitreal injection of anti-vascular endothelial growth factor agent
• Previously received intravitreal injection of steroid or gancyclovir
• Current use of steroid eye drop
• Any ocular surface disease preclude a reliable intraocular pressure measurement

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in intraocular pressure	6-month after injection	intraocular pressure change at 6-month after injection

Secondary Outcome Measures

Name	Time	Method
Number of anti-glaucoma used	6-month	Start anti-glaucoma If there is an increase in intraocular pressure over the target IOP

Trial Locations

Locations (1)

Weerawat Kiddee; 🇹🇭 Hatyai, Songkhla, Thailand