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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Eye Diseases, Injection Complication, Intraocular Pressure

Intervention / Treatment
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* Drug: Brinzolamide-brimonidine Fixed Combination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brinzolamide-brimonidine fixed combination<br>One drop of the brinzolamide-brimonidine fixed combination is instilled in the eyes of patients two hours before the intravitreal injection | Drug: Brinzolamide-brimonidine Fixed Combination<br>* In case group one drop of a fixed combination of brinzolamide-brimonidine will be instilled two hours before the injection<br>* Other names: Simbrinza 0.2%-1% Ophthalmic Suspension;|
| No Intervention: No topical IOP-lowering medication<br>No IOP-lowering drops are instilled before the intravitreal injections | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP at 1 minute post-injection | IOP will be measured by the same portable tonometer used before the injection (iCare-IC200 tonometer) | 1 minute post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP at 10 minutes post-injection | IOP will be measured by the same portable tonometer used before the injection (iCare-IC200 tonometer) | 10 minutes post-injection | 
| IOP at 30 minutes post-injection | IOP will be measured by the same portable tonometer used before the injection (iCare-IC200 tonometer) | 30 minutes post-injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anti-vascular endothelial growth factor, intraocular pressure, brinzolamide, brimonidine, fixed combination