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

Intraocular Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02474225
• Other study ID #: EC-56-168-02-4-2
• Status: Completed
• Phase: N/A
• First received: June 11, 2015
• Last updated: June 16, 2015
• Start date: December 2013
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intraocular Pressure

Intervention

Drug:
• Intravitreal injection (bevacizumab or ranibizumab)
The intravitreal anti-vascular endothelial growth factor agent of 0.1 ml of bevacizumab (2.5 mg/0.1 ml) or ranibizumab (1 mg/0.1 ml)

Locations

Country	Name	City	State
Thailand	Weerawat Kiddee	Hatyai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in intraocular pressure	intraocular pressure change at 6-month after injection	6-month after injection	Yes
Secondary	Number of anti-glaucoma used	Start anti-glaucoma If there is an increase in intraocular pressure over the target IOP	6-month	No