NCT02140450

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
Last Updated

May 16, 2014

Status Verified

May 1, 2014

Enrollment Period

1.9 years

First QC Date

May 9, 2014

Last Update Submit

May 13, 2014

Conditions

Keywords

intraocular pressure, intravitreal injection, short term

Outcome Measures

Primary Outcomes (1)

  • change in IOP

    the change in intraocular pressure after intravitreal injection of bevacizumab

    0, 5, 10, 15, 30 minutes after injection

Study Arms (5)

Timolol

ACTIVE COMPARATOR

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

Drug: Timolol

Brimonidine

ACTIVE COMPARATOR

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

Drug: Brimonidine

Acetazolamide

ACTIVE COMPARATOR

Acetazolamide tablet, 2 tabs, 2 hours before intravitreal injection

Drug: Acetazolamide

Mannitol

ACTIVE COMPARATOR

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

Drug: Mannitol

Placebo

SHAM COMPARATOR

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

Drug: Placebo

Interventions

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

Also known as: Timoptic
Timolol

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

Also known as: Alphagan
Brimonidine

Acetazolamide tablet, 2 tabs, 2 hours before intravitreal injection

Also known as: Diamox
Acetazolamide

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

Mannitol

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

Also known as: Sham
Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients who candidate for receiving intravitreal bevacizumab

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retina Research Center, Khatam eye Hospital

Mashhad, Khorasan Razavi, Iran

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

TimololBrimonidine TartrateAcetazolamideMannitolsalicylhydroxamic acid

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazinesQuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSugar AlcoholsCarbohydrates

Study Officials

  • Nasser Shoeibi, M.D.

    Retina Research Center, Mashhad University of Medical Sciences, Mashhad, Iran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Ophthalmology

Study Record Dates

First Submitted

May 9, 2014

First Posted

May 16, 2014

Study Start

February 1, 2012

Primary Completion

January 1, 2014

Study Completion

May 1, 2014

Last Updated

May 16, 2014

Record last verified: 2014-05

Locations