Completed

NCT Number: NCT03513172

Pre-Administration of Brimonidine in Intravitreal Anti-VEGF Therapy

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.

Completed

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Key information

Conditions

Post-Injection Intraocular Pressure Spikes

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc)

Drug

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 outcomes

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

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

Dr. Efrem Mandelcorn

Registry information

Official study title

Hypotensive Efficacy of Topical Prophylaxis for Intraocular Pressure Spikes Following Intravitreal Injections of Anti-vascular Endothelial Growth Factor Agents

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: May 1, 2018
Registry last updated: May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.