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

Primary Purpose

Eye Diseases, Injection Complication, Intraocular Pressure

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Brinzolamide-brimonidine Fixed Combination
Sponsored by
General Hospital of Athens Elpis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eye Diseases focused on measuring anti-vascular endothelial growth factor, intraocular pressure, brinzolamide, brimonidine, fixed combination

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • "Elpis" General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Brinzolamide-brimonidine fixed combination

No topical IOP-lowering medication

Arm Description

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

No IOP-lowering drops are instilled before the intravitreal injections

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
August 18, 2020
Last Updated
August 20, 2020
Sponsor
General Hospital of Athens Elpis
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1. Study Identification

Unique Protocol Identification Number
NCT04523844
Brief Title
Brinzolamide-brimonidine Fixed Combination for Preventing IOP Elevation After Intravitreal Anti-VEGF Injections
Official Title
Effect of Topical Prophylaxis With Brinzolamide-brimonidine Fixed Combination on Intraocular Pressure Elevation After Intravitreal Injections of Anti-vascular Endothelial Growth Factors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 11, 2020 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital of Athens Elpis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Diseases, Injection Complication, Intraocular Pressure
Keywords
anti-vascular endothelial growth factor, intraocular pressure, brinzolamide, brimonidine, fixed combination

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The investigator who will measure the IOP will be masked to group assignment.
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brinzolamide-brimonidine fixed combination
Arm Type
Active Comparator
Arm Description
One drop of the brinzolamide-brimonidine fixed combination is instilled in the eyes of patients two hours before the intravitreal injection
Arm Title
No topical IOP-lowering medication
Arm Type
No Intervention
Arm Description
No IOP-lowering drops are instilled before the intravitreal injections
Intervention Type
Drug
Intervention Name(s)
Brinzolamide-brimonidine Fixed Combination
Other Intervention Name(s)
Simbrinza 0.2%-1% Ophthalmic Suspension
Intervention Description
In case group one drop of a fixed combination of brinzolamide-brimonidine will be instilled two hours before the injection
Primary Outcome Measure Information:
Title
IOP at 1 minute post-injection
Description
IOP will be measured by the same portable tonometer used before the injection (iCare-IC200 tonometer)
Time Frame
1 minute post-injection
Secondary Outcome Measure Information:
Title
IOP at 10 minutes post-injection
Description
IOP will be measured by the same portable tonometer used before the injection (iCare-IC200 tonometer)
Time Frame
10 minutes post-injection
Title
IOP at 30 minutes post-injection
Description
IOP will be measured by the same portable tonometer used before the injection (iCare-IC200 tonometer)
Time Frame
30 minutes post-injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Dettoraki, MD, PhD
Organizational Affiliation
"Elpis" General Hospital of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Elpis" General Hospital
City
Athens
State/Province
Ambelokipi
ZIP/Postal Code
11522
Country
Greece

12. IPD Sharing Statement

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

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