- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05474716
The Effect of Topical Brimonidine on the Ocular Hemodynamics in Patients of POAG Using OCTA
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Fayoum, Egypt
- Fayoum University Hospitals
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Topical Brimonidine 0.2% bid ophthalmic solution
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in macular and peripapillary vascular densities
Time Frame: At baseline before Brimonidine and 1,2,3 months thereafter.
|
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.
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At baseline before Brimonidine and 1,2,3 months thereafter.
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Change in macular and peripapillary flow indices
Time Frame: At baseline before Brimonidine and 1,2,3 months thereafter.
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An arbitrary flow index will be indirectly calculated using the density data of optical coherence tomography angiography, intraocular pressure and arterial blood pressure measurements.
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At baseline before Brimonidine and 1,2,3 months thereafter.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in intraocular pressure
Time Frame: At baseline before Brimonidine and 1,2,3 months thereafter.
|
Comparing intraocular pressure measurements at baseline with those on subsequent visits.
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At baseline before Brimonidine and 1,2,3 months thereafter.
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Change in vascular autoregulatory capacity
Time Frame: At baseline before Brimonidine and 1,2,3 months thereafter.
|
Assessing both systemic as well as ocular vascular autoregulatory capacity making use of the 30-minute recumbency protocol as a vascular stress test.
|
At baseline before Brimonidine and 1,2,3 months thereafter.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Ocular Hypertension
- Glaucoma
- Glaucoma, Open-Angle
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Pharmaceutical Solutions
- Brimonidine Tartrate
- Ophthalmic Solutions
Other Study ID Numbers
- M 488
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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