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OpenTrials
Completed

NCT Number: NCT02140450

Effect of Antiglaucoma Agents on Short Term Intraocular Pressure Fluctuations After Intravitreal Bevacizumab Injection

To assess the effect of prophylactic antiglaucoma agents in prevention of acute intraocular pressure rise after intravitreal injection.

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Key information

Conditions

Intraocular Pressure Change in Intravitreal Injection

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Retina Research Center, Khatam eye Hospital

Mashhad, Razavi Khorasan Province, Iran

About this study

Acute intraocular pressure elevation after intravitreal injection of bevacizumab was proven.Acute intraocular pressure elevation most probably is volume related and long term intraocular pressure elevation relates to pharmacologic features of the medications which results in anatomic changes in the angle of anterior chamber.Numerous studies found an intraocular pressure elevation right after the injection and quick normalization within maximally 30 minutes.This intraocular pressure elevation which lasts about 30 minutes, can result in irreversible visual loss especially in patients with critical remaining nerve fibers in the optic nerve head, as occurs in glaucomatous patients. Is there any way to prevent or even shorten this time of intraocular pressure elevation? We tried in our study to find a suitable response for a question above, so we used several anti-glaucoma agents (Timolol, Brimonidine, Acetazolamide, Mannitol versus placebo) as a prophylaxis to prevent acute intraocular pressure elevation right after intravitreal bevacizumab injection.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • all patients who candidate for receiving intravitreal bevacizumab

Exclusion criteria

  • patients who had advanced glaucoma
  • patients who received antiglaucoma agents in the past
  • patients who had corneal scar which affect IOP measurement

Treatment and study plan

Timolol

Drug

2 drops of timolol, 10 minutes apart, 1-2 hours before intravitreal injection

Other names: Timoptic

Brimonidine

Drug

Brimonidine eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection

Other names: Alphagan

Acetazolamide

Drug

Acetazolamide tablet, 2 tabs, 2 hours before intravitreal injection

Other names: Diamox

Mannitol

Drug

Intravenous mannitol, 1.5 gram/kg, 1 hour before intravitreal injection

Placebo

Drug

Artificial tears, 2 drops, 1-2 hours before intravitreal injection

Other names: Sham

Primary outcomes

  1. change in IOP

    Time frame: 0, 5, 10, 15, 30 minutes after injection

    the change in intraocular pressure after intravitreal injection of bevacizumab

Sponsors and collaborators

Lead sponsor

Mashhad University of Medical Sciences

Other

Registry information

Official study title

Short Term Intraocular Pressure Fluctuations After Intravitreal Bevacizumab Injection: the Effect of Pretreatment With Antiglaucoma Agents

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 16, 2014
Registry last updated
May 16, 2014

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.