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Completed

NCT Number: NCT02474225

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Weerawat Kiddee

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Intravitreal injection (bevacizumab or ranibizumab)

Drug

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)

Other names: anti-vascular endothelial growth factor agent

Primary outcomes

  1. Change from baseline in intraocular pressure

    Time frame: 6-month after injection

    intraocular pressure change at 6-month after injection

Secondary outcomes

  1. Number of anti-glaucoma used

    Time frame: 6-month

    Start anti-glaucoma If there is an increase in intraocular pressure over the target IOP

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 17, 2015
Registry last updated
Jun 17, 2015

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.

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