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

May 13, 2014 updated by: Nasser Shoeibi, Mashhad University of Medical Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Khorasan Razavi
      • Mashhad, Khorasan Razavi, Iran, Islamic Republic of
        • Retina Research Center, Khatam eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Timolol
Timolol eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection
Drug: Timolol
2 drops of timolol, 10 minutes apart, 1-2 hours before intravitreal injection
Other Names:
  • Timoptic
Active Comparator: Brimonidine
Brimonidine eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection
Drug: Brimonidine
Brimonidine eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection
Other Names:
  • Alphagan
Active Comparator: Acetazolamide
Acetazolamide tablet, 2 tabs, 2 hours before intravitreal injection
Drug: Acetazolamide
Acetazolamide tablet, 2 tabs, 2 hours before intravitreal injection
Other Names:
  • Diamox
Active Comparator: Mannitol
Intravenous mannitol, 1.5 gram/kg, 1 hour before intravitreal injection
Drug: Mannitol
Intravenous mannitol, 1.5 gram/kg, 1 hour before intravitreal injection
Sham Comparator: Placebo
Artificial tears, 2 drops, 1-2 hours before intravitreal injection
Drug: Placebo
Artificial tears, 2 drops, 1-2 hours before intravitreal injection
Other Names:
  • Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in IOP
Time Frame: 0, 5, 10, 15, 30 minutes after injection
the change in intraocular pressure after intravitreal injection of bevacizumab
0, 5, 10, 15, 30 minutes after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Investigators

  • Principal Investigator: Nasser Shoeibi, M.D., Retina Research Center, Mashhad University of Medical Sciences, Mashhad, Iran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

May 9, 2014

First Submitted That Met QC Criteria

May 13, 2014

First Posted (Estimate)

May 16, 2014

Study Record Updates

Last Update Posted (Estimate)

May 16, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 910292

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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