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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-11

Study Completion Date

2020-07-30

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.

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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.

Conditions

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Eye Diseases Injection Complication Intraocular Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

The investigator who will measure the IOP will be masked to group assignment.

Study Groups

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Brinzolamide-brimonidine fixed combination

One drop of the brinzolamide-brimonidine fixed combination is instilled in the eyes of patients two hours before the intravitreal injection

Group Type ACTIVE_COMPARATOR

Brinzolamide-brimonidine Fixed Combination

Intervention Type DRUG

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

No topical IOP-lowering medication

No IOP-lowering drops are instilled before the intravitreal injections

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Brinzolamide-brimonidine Fixed Combination

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

Intervention Type DRUG

Other Intervention Names

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Simbrinza 0.2%-1% Ophthalmic Suspension

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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No