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Trial record 33 of 152 for:    Brimonidine

Pre-Administration of Brimonidine in Intravitreal Anti-VEGF Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03513172
Recruitment Status : Completed
First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
Dr. Efrem Mandelcorn
Information provided by (Responsible Party):
Tina Felfeli, University of Toronto

Brief Summary:
In this study, investigators will be examining the intraocular pressure lowering effect of brimonidine 0.15% when administered 20min prior to intravitreal anti-VEGF injection.

Condition or disease Intervention/treatment Phase
Post-Injection Intraocular Pressure Spikes Drug: topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc) Not Applicable

Detailed Description:
A total of 55 consecutive patients undergoing anti-VEGF intravitreal injections (received ≥1 treatments) for age-related macular degeneration (AMD), diabetic macular edema (DME) or macula edema secondary to branch retinal vein occlusion (BRVO) will be prospectively recruited between December 2016 and July 2017. Patients will be randomly assigned based on a pre-determined allocation sequence to receive topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc) during either the first or second of two consecutive visits. A standard protocol for sterile preparation with topical 5% povidone-iodine solution will be followed. Pre-injection IOP measurements will be recorded prior to the instillation of dilating agents and brimonidine tartrate. A total of three IOP measurements will be taken by certified ophthalmic technicians at immediately after the injection (T0), 10 minutes after (T10) and 20 minutes after (T20) injection.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Hypotensive Efficacy of Topical Prophylaxis for Intraocular Pressure Spikes Following Intravitreal Injections of Anti-vascular Endothelial Growth Factor Agents
Actual Study Start Date : December 15, 2016
Actual Primary Completion Date : July 15, 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Brimonidine Pre-Administration During First Visit Drug: topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc)
The rapid hypotensive effects of topical alpha2-agonists such as brimonidine tartrate on decreasing aqueous production and increasing uveoscleral outflow, in addition to their neuroprotective properties, make them an attractive option for prophylactic treatment of post-injection IOP spikes.

Active Comparator: Brimonidine Pre-Administration During Second Visit Drug: topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc)
The rapid hypotensive effects of topical alpha2-agonists such as brimonidine tartrate on decreasing aqueous production and increasing uveoscleral outflow, in addition to their neuroprotective properties, make them an attractive option for prophylactic treatment of post-injection IOP spikes.




Primary Outcome Measures :
  1. Change in Post-Injection Intraocular Pressure Spike [ Time Frame: Change from immediately, 10 minutes and 20 minutes after injection ]
    the intraocular pressure lowering effect of brimonidine 0.15% ophthalmic eye drop when administered 20 minutes prior to intravitreal anti-VEGF injection



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • received ≥1 treatments for age-related macular degeneration (AMD), diabetic macular edema (DME) or macula edema secondary to branch retinal vein occlusion (BRVO)

Exclusion Criteria:

  • baseline diagnosis of glaucoma
  • baseline IOP during last visit of greater than 21 mmHg
  • ongoing use of topical medications (eg. corticosteroids)
  • pseudophakic with an anterior chamber intraocular lens
  • history of ocular conditions that may impact IOP (eg. pseudoexfoliation)
  • previous in-office (eg. laser peripheral iridotomy) and vitreoretinal surgical procedures (eg. pars plana vitrectomy).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513172


Sponsors and Collaborators
University of Toronto
Dr. Efrem Mandelcorn
Investigators
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Principal Investigator: Efrem Mandelcorn, MD, FRCSC University Health Network, Toronto

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tina Felfeli, Medical Student, University of Toronto
ClinicalTrials.gov Identifier: NCT03513172     History of Changes
Other Study ID Numbers: 15-9762-B
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Tina Felfeli, University of Toronto:
Intraocular Pressure
Anti-VEGF Agents
alpha2-agonists

Additional relevant MeSH terms:
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Brimonidine Tartrate
Endothelial Growth Factors
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Growth Substances