Clinical trial NCT03513172: Pre-Administration of Brimonidine in Intravitreal Anti-VEGF Therapy
Official title: Hypotensive Efficacy of Topical Prophylaxis for Intraocular Pressure Spikes Following Intravitreal Injections of Anti-vascular Endothelial Growth Factor Agents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Injection Intraocular Pressure Spikes
Keywords: Intraocular Pressure
Anti-VEGF Agents
alpha2-agonists
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Dr. Efrem Mandelcorn
First posted: 2018-05-01
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility 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).

Primary outcomes:
measure: Change in Post-Injection Intraocular Pressure Spike
timeFrame: Change from immediately, 10 minutes and 20 minutes after injection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Health Network, Toronto
name: Efrem Mandelcorn, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kampougeris G, Spyropoulos D, Mitropoulou A. Intraocular Pressure rise after Anti-VEGF Treatment: Prevalence, Possible Mechanisms and Correlations. J Curr Glaucoma Pract. 2013 Jan-Apr;7(1):19-24. doi: 10.5005/jp-journals-10008-1132. Epub 2013 Jan 15.
citation: Kim YJ, Sung KR, Lee KS, Joe SG, Lee JY, Kim JG, Yoon YH. Long-term effects of multiple intravitreal antivascular endothelial growth factor injections on intraocular pressure. Am J Ophthalmol. 2014 Jun;157(6):1266-1271.e1. doi: 10.1016/j.ajo.2014.02.035. Epub 2014 Feb 18.
citation: Hoang QV, Mendonca LS, Della Torre KE, Jung JJ, Tsuang AJ, Freund KB. Effect on intraocular pressure in patients receiving unilateral intravitreal anti-vascular endothelial growth factor injections. Ophthalmology. 2012 Feb;119(2):321-6. doi: 10.1016/j.ophtha.2011.08.011. Epub 2011 Nov 4.
citation: Tseng JJ, Vance SK, Della Torre KE, Mendonca LS, Cooney MJ, Klancnik JM, Sorenson JA, Freund KB. Sustained increased intraocular pressure related to intravitreal antivascular endothelial growth factor therapy for neovascular age-related macular degeneration. J Glaucoma. 2012 Apr-May;21(4):241-7. doi: 10.1097/IJG.0b013e31820d7d19.
citation: Aref AA. Management of immediate and sustained intraocular pressure rise associated with intravitreal antivascular endothelial growth factor injection therapy. Curr Opin Ophthalmol. 2012 Mar;23(2):105-10. doi: 10.1097/ICU.0b013e32834ff41d.
citation: Felfeli T, Hostovsky A, Trussart R, Yan P, Brent MH, Mandelcorn ED. Hypotensive efficacy of topical brimonidine for intraocular pressure spikes following intravitreal injections of antivascular endothelial growth factor agents: a randomised crossover trial. Br J Ophthalmol. 2019 Oct;103(10):1388-1394. doi: 10.1136/bjophthalmol-2018-312603. Epub 2018 Dec 20.