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

Sponsor

General Hospital of Athens Elpis (Other)

Overall Status

Completed

CT.gov ID

NCT04523844

Collaborator

(none)

Enrollment

Location

Arms

2.6

Actual Duration (Months)

17.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Eye Diseases Injection Complication Intraocular Pressure	Drug: Brinzolamide-brimonidine Fixed Combination	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 11, 2020

Actual Primary Completion Date :

Jul 30, 2020

Actual Study Completion Date :

Jul 30, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

IOP at 1 minute post-injection [1 minute post-injection]
IOP will be measured by the same portable tonometer used before the injection (iCare-IC200 tonometer)

Secondary Outcome Measures

IOP at 10 minutes post-injection [10 minutes post-injection]
IOP will be measured by the same portable tonometer used before the injection (iCare-IC200 tonometer)
IOP at 30 minutes post-injection [30 minutes post-injection]
IOP will be measured by the same portable tonometer used before the injection (iCare-IC200 tonometer)