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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Intraocular Pressure Change in Intravitreal Injection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Timolol

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

Group Type ACTIVE_COMPARATOR

Timolol

Intervention Type DRUG

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

Brimonidine

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

Group Type ACTIVE_COMPARATOR

Brimonidine

Intervention Type DRUG

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

Acetazolamide

Acetazolamide tablet, 2 tabs, 2 hours before intravitreal injection

Group Type ACTIVE_COMPARATOR

Acetazolamide

Intervention Type DRUG

Acetazolamide tablet, 2 tabs, 2 hours before intravitreal injection

Mannitol

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

Group Type ACTIVE_COMPARATOR

Mannitol

Intervention Type DRUG

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

Placebo

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

Group Type SHAM_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Timolol

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

Intervention Type DRUG

Brimonidine

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

Intervention Type DRUG

Acetazolamide

Acetazolamide tablet, 2 tabs, 2 hours before intravitreal injection

Intervention Type DRUG

Mannitol

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Timoptic Alphagan Diamox Sham

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes