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

Sponsor

Mashhad University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT02140450

Collaborator

(none)

Enrollment

Location

Arms

26.9

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Intraocular Pressure Change in Intravitreal Injection	Drug: Timolol Drug: Brimonidine Drug: Acetazolamide Drug: Mannitol Drug: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

change in IOP [0, 5, 10, 15, 30 minutes after injection]
the change in intraocular pressure after intravitreal injection of bevacizumab

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retina Research Center, Khatam eye Hospital	Mashhad	Khorasan Razavi	Iran, Islamic Republic of

Sponsors and Collaborators

Mashhad University of Medical Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nasser Shoeibi, Assistant Professor of Ophthalmology, Mashhad University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT02140450

Other Study ID Numbers:

910292

First Posted:

May 16, 2014

Last Update Posted:

May 16, 2014

Last Verified:

May 1, 2014

Keywords provided by Nasser Shoeibi, Assistant Professor of Ophthalmology, Mashhad University of Medical Sciences

intraocular pressure, intravitreal injection, short term

Additional relevant MeSH terms:

Study Results

No Results Posted as of May 16, 2014