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

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

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.

Study Overview

• Status: Completed
• Conditions: Eye Diseases; Intraocular Pressure; Injection Complication
• Intervention / Treatment: Drug: Brinzolamide-brimonidine Fixed Combination

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Ambelokipi
    • Athens, Ambelokipi, Greece, 11522
      • "Elpis" General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Drug: Brinzolamide-brimonidine Fixed Combination; 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
NO_INTERVENTION: No topical IOP-lowering medication; No IOP-lowering drops are instilled before the intravitreal injections

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: General Hospital of Athens Elpis
• Investigators: Principal Investigator: Maria Dettoraki, MD, PhD, "Elpis" General Hospital of Athens

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 11, 2020
• Primary Completion (ACTUAL): July 30, 2020
• Study Completion (ACTUAL): July 30, 2020

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (ACTUAL): August 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: intraocular pressure; anti-vascular endothelial growth factor; fixed combination; brimonidine; brinzolamide
• Additional Relevant MeSH Terms: Eye Diseases; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Carbonic Anhydrase Inhibitors; Brimonidine Tartrate; Brinzolamide
• Other Study ID Numbers: 1992

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No