Pre-Administration of Brimonidine in Intravitreal Anti-VEGF Therapy

Post-Injection Intraocular Pressure Spikes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03513172
• Other study ID #: 15-9762-B
• Status: Completed
• Phase: N/A
• Start date: December 15, 2016
• Est. completion date: September 1, 2017

Study information

• Verified date: April 2018
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 1, 2017
• Est. primary completion date: July 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Post-Injection Intraocular Pressure Spikes

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Dr. Efrem Mandelcorn

References & Publications (5)

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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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