Pre-Administration of Brimonidine in Intravitreal Anti-VEGF Therapy

Not Applicable

Completed

• Conditions: Post-Injection Intraocular Pressure Spikes
• Interventions: Drug: topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc)

• Registration Number: NCT03513172
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-12-15
• Primary Completion: 2017-07-15
• Study Completion: 2017-09-01
• Status Verified: 2018-04
• Study First Submitted: 2018-04-17
• Study First Submitted QC: 2018-04-27
• Last Update Submitted: 2018-04-27
• Study First Posted: 2018-05-01
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Brimonidine Pre-Administration During Second Visit	topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc)	-
Brimonidine Pre-Administration During First Visit	topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc)	-

Primary Outcome Measures

Name	Time	Method
Change in Post-Injection Intraocular Pressure Spike	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