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Pre-Administration of Brimonidine in Intravitreal Anti-VEGF Therapy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03513172
Enrollment
55
Registered
2018-05-01
Start date
2016-12-15
Completion date
2017-09-01
Last updated
2018-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Injection Intraocular Pressure Spikes

Keywords

Intraocular Pressure, Anti-VEGF Agents, alpha2-agonists

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.

Interventions

DRUGtopical 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.

Sponsors

Dr. Efrem Mandelcorn
CollaboratorUNKNOWN
University of Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Change in Post-Injection Intraocular Pressure SpikeChange from immediately, 10 minutes and 20 minutes after injectionthe intraocular pressure lowering effect of brimonidine 0.15% ophthalmic eye drop when administered 20 minutes prior to intravitreal anti-VEGF injection

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026