Pre-Administration of Brimonidine in Intravitreal Anti-VEGF Therapy

University of Toronto

Status: Completed

Conditions: Post-Injection Intraocular Pressure Spikes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03513172

15-9762-B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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55 participants in 2 patient groups

Brimonidine Pre-Administration During First Visit

Active Comparator group

Treatment:

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

Brimonidine Pre-Administration During Second Visit

Active Comparator group

Treatment:

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