Skip to main content
OpenTrials
Completed

NCT Number: NCT04523844

Brinzolamide-brimonidine Fixed Combination for Preventing IOP Elevation After Intravitreal Anti-VEGF Injections

This study aims to evaluate the effect of topical prophylaxis with brinzolamide-brimonidine fixed combination on short-term intraocular pressure (IOP) elevation after intravitreal injections of anti-vascular endothelial growth factors (anti-VEGF).

Patients scheduled for treatment with intravitreal injections of anti-VEGF will be randomly divided into two groups. In control group no prophylactic medication will be used, whereas in case group one drop of brinzolamide-brimonidine fixed combination will be instilled two hours before the injection. IOP will be measured before the injection, 1 minute after the injection, 10 minutes and 30 minutes post-injection in all eyes. In case group, the pre-injection IOP will be measured prior to the administration of the fixed combination of brinzolamide-brimonidine. The iCare (IC200) tonometer will be used for IOP measurements at all time points.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Eye Diseases Injection Complication Intraocular Pressure

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

"Elpis" General Hospital

Athens, Ambelokipi, 11522, Greece

About this study

The intravitreal anti-VEGF (ranibizumab, bevacizumab, pegaptanib and aflibercept) are commonly used in the treatment of diabetic macular edema, neovascular age-related macular degeneration and other pathologies characterized by retinal or choroidal neovascularization. Intravitreal injections οf anti-VEGF agents result in an immediate and transient increase in IOP, which returns to normal within a short period of time, typically within thirty minutes. Repeated intravitreal injections and prolonged treatments seem to be associated with sustained elevation of IOP, leading to the initiation of ocular hypotensive medication and glaucoma filtration surgery. A fixed-dose combination of brinzolamide 1%, a carbonic anhydrase inhibitor, and brimonidine 0,2%, an alpha 2 adrenergic receptor agonist, represents a safe and effective drug in glaucoma treatment and its ocular hypotensive effect has been demonstrated similar to or better than the unfixed combinations of its component drugs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for treatment with intravitreal injections of anti-vascular endothelial growth factors

Exclusion criteria

  • history of glaucoma or ocular hypertension
  • use of topical medications (e.g. IOP-lowering medication, corticosteroids)
  • pseudoexfoliation
  • pigment dispersion syndrome
  • corneal diseases
  • active intraocular inflammation
  • any intraocular surgery in the last 6 months

Treatment and study plan

Brinzolamide-Brimonidine fixed combination

Drug

In case group one drop of a fixed combination of brinzolamide-brimonidine will be instilled two hours before the injection

Other names: Simbrinza 0.2%-1% Ophthalmic Suspension

Primary outcomes

  1. IOP at 1 minute post-injection

    Time frame: 1 minute post-injection

    IOP will be measured by the same portable tonometer used before the injection (iCare-IC200 tonometer)

Secondary outcomes

  1. IOP at 10 minutes post-injection

    Time frame: 10 minutes post-injection

    IOP will be measured by the same portable tonometer used before the injection (iCare-IC200 tonometer)

  2. IOP at 30 minutes post-injection

    Time frame: 30 minutes post-injection

    IOP will be measured by the same portable tonometer used before the injection (iCare-IC200 tonometer)

Sponsors and collaborators

Lead sponsor

General Hospital of Athens Elpis

Other

Registry information

Official study title

Effect of Topical Prophylaxis With Brinzolamide-brimonidine Fixed Combination on Intraocular Pressure Elevation After Intravitreal Injections of Anti-vascular Endothelial Growth Factors

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 24, 2020
Registry last updated
Aug 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.