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

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

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.

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

Conditions
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Intraocular Pressure Change in Intravitreal Injection

Intervention / Treatment
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* Drug: Timolol
* Drug: Brimonidine
* Drug: Acetazolamide
* Drug: Mannitol
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraocular pressure, intravitreal injection, short term