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

NCT04523844 | Completed

• 1 other identifier: 1992
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Eye Diseases; Injection Complication; Intraocular Pressure

Keywords

anti-vascular endothelial growth factor; intraocular pressure; brinzolamide; brimonidine; fixed combination

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• IOP at 10 minutes post-injection

  10 minutes post-injection

• IOP at 30 minutes post-injection

  30 minutes post-injection

Study Arms (2)

Brinzolamide-brimonidine fixed combination

ACTIVE COMPARATOR

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

No topical IOP-lowering medication

NO INTERVENTION

No IOP-lowering drops are instilled before the intravitreal injections

Interventions

Brinzolamide-brimonidine Fixed Combination DRUG

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

Also known as: Simbrinza 0.2%-1% Ophthalmic Suspension

Brinzolamide-brimonidine fixed combination

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for treatment with intravitreal injections of anti-vascular endothelial growth factors

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital of Athens Elpis: lead

Study Sites (1)

"Elpis" General Hospital

Athens, Ambelokipi, 11522, Greece

Location

MeSH Terms

Conditions

Eye Diseases

Study Officials

• Maria Dettoraki, MD, PhD

  "Elpis" General Hospital of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator who will measure the IOP will be masked to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Locum Specialist, Department of Ophthalmology

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 24, 2020
• Study Start: May 11, 2020
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: August 24, 2020

Record last verified: 2020-08

Locations

GR (1)