Pre-Administration of Brimonidine in Intravitreal Anti-VEGF Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Post-Injection Intraocular Pressure Spikes

Intervention / Treatment
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* Drug: topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc)


Participation Criteria
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Eligibility Criteria
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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).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brimonidine Pre-Administration During First Visit<br> | Drug: topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc)<br>* 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.<br>|
| Active Comparator: Brimonidine Pre-Administration During Second Visit<br> | Drug: topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Post-Injection Intraocular Pressure Spike | the intraocular pressure lowering effect of brimonidine 0.15% ophthalmic eye drop when administered 20 minutes prior to intravitreal anti-VEGF injection | Change from immediately, 10 minutes and 20 minutes after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular Pressure, Anti-VEGF Agents, alpha2-agonists