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

Not Applicable

Completed

• Conditions: Intraocular Pressure Change in Intravitreal Injection
• Interventions: Drug: Timolol; Drug: Brimonidine; Drug: Acetazolamide; Drug: Mannitol; Drug: Placebo

• Registration Number: NCT02140450
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

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

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 Timeline

• Study Start: 2012-02
• Primary Completion: 2014-01
• Status Verified: 2014-05
• Study Completion: 2014-05
• Study First Submitted: 2014-05-09
• Study First Submitted QC: 2014-05-13
• Last Update Submitted: 2014-05-13
• Study First Posted: 2014-05-16
• Last Update Posted: 2014-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Timolol	Timolol	Timolol eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection
Brimonidine	Brimonidine	Brimonidine eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection
Acetazolamide	Acetazolamide	Acetazolamide tablet, 2 tabs, 2 hours before intravitreal injection
Mannitol	Mannitol	Intravenous mannitol, 1.5 gram/kg, 1 hour before intravitreal injection
Placebo	Placebo	Artificial tears, 2 drops, 1-2 hours before intravitreal injection

Primary Outcome Measures

Name	Time	Method
change in IOP	0, 5, 10, 15, 30 minutes after injection	the change in intraocular pressure after intravitreal injection of bevacizumab

Trial Locations

Locations (1)

Retina Research Center, Khatam eye Hospital; 🇮🇷 Mashhad, Khorasan Razavi, Iran, Islamic Republic of