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

Eye Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04523844
• Other study ID #: 1992
• Status: Completed
• Phase: N/A
• Start date: May 11, 2020
• Est. completion date: July 30, 2020

Study information

• Verified date: August 2020
• Source: General Hospital of Athens Elpis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Injection Complication
• Intraocular Pressure

Intervention

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

Locations

Country	Name	City	State
Greece	"Elpis" General Hospital	Athens	Ambelokipi

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Athens Elpis

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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