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CompletedNCT02140450Updated May 16, 2014

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

An interventional study of Timolol and Brimonidine in Intraocular Pressure Change in Intravitreal Injection, sponsored by Mashhad University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-16.

Sponsored by Mashhad University of Medical Sciences · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Intraocular Pressure Change in Intravitreal Injection

Keywords

  • intraocular pressure, intravitreal injection, short term
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In context

Lead sponsor

Mashhad University of Medical Sciences is the lead sponsor of 90 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • all patients who candidate for receiving intravitreal bevacizumab

Exclusion criteria

Exclusion Criteria:

  • patients who had advanced glaucoma
  • patients who received antiglaucoma agents in the past
  • patients who had corneal scar which affect IOP measurement
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    Timolol

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

    Drug: Timolol

  • Active comparator
    Brimonidine

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

    Drug: Brimonidine

  • Active comparator
    Acetazolamide

    Acetazolamide tablet, 2 tabs, 2 hours before intravitreal injection

    Drug: Acetazolamide

  • Active comparator
    Mannitol

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

    Drug: Mannitol

  • Sham comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugTimolol

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

    Also known as: Timoptic

  • DrugBrimonidine

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

    Also known as: Alphagan

  • DrugAcetazolamide

    Acetazolamide tablet, 2 tabs, 2 hours before intravitreal injection

    Also known as: Diamox

  • DrugMannitol

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

  • DrugPlacebo

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

    Also known as: Sham

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What researchers measure

Primary outcomes

  1. change in IOP

    the change in intraocular pressure after intravitreal injection of bevacizumab

    Time frame: 0, 5, 10, 15, 30 minutes after injection

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Study locations

1 site
  • Retina Research Center, Khatam eye Hospital
    Mashhad, Khorasan Razavi, Iran, Islamic Republic of
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References and documents

Publications

  • Shoeibi N, Ghosi Z, Jafari H, Omidtabrizi A. Effect of antiglaucoma agents on short-term intraocular pressure fluctuations after intravitreal bevacizumab injections. Int Ophthalmol. 2021 Mar;41(3):1081-1090. doi: 10.1007/s10792-020-01667-z. Epub 2021 Jan 2. PubMed 33389369 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02140450
Lead sponsor
Mashhad University of Medical Sciences
Responsible party
Nasser Shoeibi (Assistant Professor of Ophthalmology, Mashhad University of Medical Sciences) — Principal investigator
First posted
May 16, 2014
Start date
Feb 2012
Primary completion
Jan 2014
Completion
May 2014
Last update
May 16, 2014

Study contacts

Nasser Shoeibi, M.D.
principal investigator · Retina Research Center, Mashhad University of Medical Sciences, Mashhad, Iran

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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