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

NCT05474716 | Completed Phase 4

• 1 other identifier: M 488
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  At baseline before Brimonidine and 1,2,3 months thereafter.

• 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.

  At baseline before Brimonidine and 1,2,3 months thereafter.

Secondary Outcomes (2)

• Change in intraocular pressure

  At baseline before Brimonidine and 1,2,3 months thereafter.

• Change in vascular autoregulatory capacity

  At baseline before Brimonidine and 1,2,3 months thereafter.

Study Arms (1)

Topical Brimonidine 0.2% bid ophthalmic solution

EXPERIMENTAL

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.

Drug: Brimonidine tartrate 0.2% ophthalmic solution

Interventions

Brimonidine tartrate 0.2% ophthalmic solution DRUG

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.

Topical Brimonidine 0.2% bid ophthalmic solution

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum University Hospitals

Al Fayyum, Egypt

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Brimonidine Tartrate; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant of ophthalmology

Model Details: A longitudinal, prospective, interventional, uncontrolled study

Study Record Dates

• First Submitted: January 30, 2022
• First Posted: July 26, 2022
• Study Start: May 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: July 1, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)