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The Effect of Topical Brimonidine on the Ocular Hemodynamics in Patients of POAG Using OCTA

Primary Purpose

Glaucoma, Primary Open Angle, Ocular Blood Flow, Optical Coherence Tomography Angiography

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Brimonidine tartrate 0.2% ophthalmic solution
Sponsored by
Fayoum University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Primary Open Angle

Eligibility Criteria

25 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary open angle glaucoma patients.
  • Brimonidine naiive.
  • Medication naiive or on a fixed antiglaucoma medication for at least a month prior to commencing Brimonidine.

Exclusion Criteria:

  • Glaucomas other than primary open angle glaucoma.
  • Other comorbid diseses both ocular and systemic that might confound the density and flow measurements ( hypertension, diabetes, vasculitis, MacTel, Uveitis)
  • Comorbid diseases that constitute relative or absolute contraindication to Brimonidine ( pregnancy, lactation, bronchial asthma, cardiovascular diseases)
  • Prior use of Brimonidine.
  • A change in the glaucoma medication regimen within Less than one month at time of presentation.
  • Allergy to Brimonidine or related compounds.

Sites / Locations

  • Fayoum University Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Topical Brimonidine 0.2% bid ophthalmic solution

Arm Description

Topical Brimonidine tartrate 0.2% ophthalmic solution used twice daily. It is a selective alpha 2 adrenergic agonist that is used as an ocular hypotensive in glaucoma and ocular hypertension patients and has proposed neuroprotective effect.

Outcomes

Primary Outcome Measures

Change in macular and peripapillary vascular densities
The vascular density measured by optical coherence tomography angiography represents the percentage area of flow-positive regions compared to the whole imaged area. Measured densities include (superficial and deep vascular densities) both of the macular area as well as radial peripapillary capillary density of the parapapillary area.
Change in macular and peripapillary flow indices
An arbitrary flow index will be indirectly calculated using the density data of optical coherence tomography angiography, intraocular pressure and arterial blood pressure measurements.

Secondary Outcome Measures

Change in intraocular pressure
Comparing intraocular pressure measurements at baseline with those on subsequent visits.
Change in vascular autoregulatory capacity
Assessing both systemic as well as ocular vascular autoregulatory capacity making use of the 30-minute recumbency protocol as a vascular stress test.

Full Information

First Posted
January 30, 2022
Last Updated
July 23, 2022
Sponsor
Fayoum University
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1. Study Identification

Unique Protocol Identification Number
NCT05474716
Brief Title
The Effect of Topical Brimonidine on the Ocular Hemodynamics in Patients of POAG Using OCTA
Official Title
The Effect of Topical Brimonidine on the Hemodynamics of the Optic Nerve Head and Retinochoroidal Circulation in Patients of Primary Open Angle Glaucoma Using Optical Coherence Tomography Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University

4. Oversight

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

5. Study Description

Brief Summary
Topical Brimonidine is a well-established topical antigalucoma, ocular hypotensive therapeutic that has been in use since 1996. Brimonidine stands out among other topical ocular hypotensives in that it has a neuroprotective effect that is independent of IOP reduction. This has been demonstrated in multiple animal and human controlled studies both in vivo and in vitro. The mechanisms proposed so far to account for this neuroprotection focus mainly on molecular level antiapoptotic effects and modulation of some excitatory stimuli like glutamate. In this study we try to test the hypothesis that a positive hemodynamic profile of Brimonidine on ocular blood flow may be responsible at least in part for its unique neuroprotective effects.
Detailed Description
Study Design: A prospective, longitudinal, interventional, uncontrolled study Participants: primary open angle glaucoma patients recruited during the period of study from the fayoum university hospital ophthalmic outpatient clinic. Methods: Primary open angle glaucoma patients that are Brimonidine naiive and at the same time either medication naiive or have been on a fixed antiglaucoma medication for at least a month prior will be commenced on Brimonidine 0.2% bid with prior baseline imaging by OCT angiography (Optovue) of macula 6*6 mm and ONH 4.5*4.5 mm. After commencing Brimonidine patients will be followed up by OCT angiography at three visits assigned for 1,2,3 months after commencing Brimonidine. Every time the patient is imaged by OCT, imaging is done twice, once in a seated position at presentation and another- also in a seated position-, but after a protocol of right recumbency for 30 minutes in order to produce a postural position change as a vascular stress test to assess autoregulatory capacity of ocular and systemic circulation. At each visit, IOP and arterial blood pressure are measured both in the seated position and after the 30-minute recumbency protocol in order to mathematically calculate the mean ocular perfusion pressure that will be correlated with OCT angiography data including vascular density, as well as indirect parameters of blood flow. Data will be statistically analysed using the SPSS software.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Primary Open Angle, Ocular Blood Flow, Optical Coherence Tomography Angiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
A longitudinal, prospective, interventional, uncontrolled study
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical Brimonidine 0.2% bid ophthalmic solution
Arm Type
Experimental
Arm Description
Topical Brimonidine tartrate 0.2% ophthalmic solution used twice daily. It is a selective alpha 2 adrenergic agonist that is used as an ocular hypotensive in glaucoma and ocular hypertension patients and has proposed neuroprotective effect.
Intervention Type
Drug
Intervention Name(s)
Brimonidine tartrate 0.2% ophthalmic solution
Intervention Description
Topical Brimonidine tartrate 0.2% bid ophthalmic solution. A selective alpha 2 adrenergic agonist with ocular hypotensive and neuroprotective properties used in glaucoma and ocular hypertension.
Primary Outcome Measure Information:
Title
Change in macular and peripapillary vascular densities
Description
The vascular density measured by optical coherence tomography angiography represents the percentage area of flow-positive regions compared to the whole imaged area. Measured densities include (superficial and deep vascular densities) both of the macular area as well as radial peripapillary capillary density of the parapapillary area.
Time Frame
At baseline before Brimonidine and 1,2,3 months thereafter.
Title
Change in macular and peripapillary flow indices
Description
An arbitrary flow index will be indirectly calculated using the density data of optical coherence tomography angiography, intraocular pressure and arterial blood pressure measurements.
Time Frame
At baseline before Brimonidine and 1,2,3 months thereafter.
Secondary Outcome Measure Information:
Title
Change in intraocular pressure
Description
Comparing intraocular pressure measurements at baseline with those on subsequent visits.
Time Frame
At baseline before Brimonidine and 1,2,3 months thereafter.
Title
Change in vascular autoregulatory capacity
Description
Assessing both systemic as well as ocular vascular autoregulatory capacity making use of the 30-minute recumbency protocol as a vascular stress test.
Time Frame
At baseline before Brimonidine and 1,2,3 months thereafter.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary open angle glaucoma patients. Brimonidine naiive. Medication naiive or on a fixed antiglaucoma medication for at least a month prior to commencing Brimonidine. Exclusion Criteria: Glaucomas other than primary open angle glaucoma. Other comorbid diseses both ocular and systemic that might confound the density and flow measurements ( hypertension, diabetes, vasculitis, MacTel, Uveitis) Comorbid diseases that constitute relative or absolute contraindication to Brimonidine ( pregnancy, lactation, bronchial asthma, cardiovascular diseases) Prior use of Brimonidine. A change in the glaucoma medication regimen within Less than one month at time of presentation. Allergy to Brimonidine or related compounds.
Facility Information:
Facility Name
Fayoum University Hospitals
City
Fayoum
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Topical Brimonidine on the Ocular Hemodynamics in Patients of POAG Using OCTA

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