Peripapillary Blood Flow After Use of Anti-glaucoma Medications: An OCT Angiography Study

NCT03323164 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 17-636E
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the possible acute changes in peripapillary blood flow after instillation of antiglaucoma medications in patients with primary open angle glaucoma (POAG), normal tension glaucoma (NTG), or ocular hypertension (OHTN) using Optical Coherence Tomography (OCT) angiography.

Conditions

Glaucoma; Drugs; Normal Tension Glaucoma; Primary Open-angle Glaucoma

Outcome Measures

Primary Outcomes (6)

• Changes in Vessel Density in Treatment Groups Assessed by OCT Angiography

  Percent change in peripapillary vessel density detected by OCT (optical coherence tomography) Angiography using spectrum amplitude decorrelation angiography (SSADA) algorithm with the use of topical brimonidine or timolol eye drops to lower eye pressure.

  5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan)

• Changes in Flow Index in Treatment Groups Assessed by OCT Angiography

  Percent change in peripapillary Flow Index detected by OCT (optical coherence tomography) Angiography using spectrum amplitude decorrelation angiography (SSADA) algorithm with the use of topical brimonidine or timolol eye drops to lower eye pressure.

  5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan)

• Comparison of Percent Changes in Peripapillary Vessel Density in Treatment Groups Assessed by OCT Angiography

  Comparison of the percent change in peripapillary vessel density detected by OCT (optical coherence tomography) Angiography using spectrum amplitude decorrelation angiography (SSADA) algorithm before and after the use of topical brimonidine or timolol eye drops to lower eye pressure. The Control groups represent the percent changes in vessel density after using artificial tears. The medicine groups (Brimonidine/Timolol) represents the percent changes in vessel density after using topical brimonidine or timolol drops to lower eye pressure.

  5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan)

• Comparison of Percent Changes in Peripapillary Flow Index in Treatment Groups Assessed by OCT Angiography

  Comparison of the percent change in peripapillary flow index detected by OCT (optical coherence tomography) Angiography using spectrum amplitude decorrelation angiography (SSADA) algorithm before and after the use of topical brimonidine or timolol eye drops to lower eye pressure. The Control groups represent the percent changes in flow index after using artificial tears. The medicine groups (Brimonidine/Timolol) represents the percent changes in flow index after using topical brimonidine or timolol drops to lower eye pressure.

  5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan)

• Comparison of Percent Changes in Optic Nerve Head Vessel Density in Treatment Groups Assessed by OCT Angiography

  Comparison of the percent change in optic nerve head vessel density detected by OCT (optical coherence tomography) Angiography using spectrum amplitude decorrelation angiography (SSADA) algorithm before and after the use of topical brimonidine or timolol eye drops to lower eye pressure. The Control groups represent the percent changes in vessel density after using artificial tears. The medicine groups (Brimonidine/Timolol) represents the percent changes in vessel density after using topical brimonidine or timolol drops to lower eye pressure.

  5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan)

• Comparison of Percent Changes in Optic Nerve Head Flow Index in Treatment Groups Assessed by OCT Angiography

  Comparison of the percent change in Optic Nerve Head Flow Index detected by OCT (optical coherence tomography) Angiography using spectrum amplitude decorrelation angiography (SSADA) algorithm before and after the use of topical brimonidine or timolol eye drops to lower eye pressure. The Control groups represent the percent changes in flow index after using artificial tears. The medicine groups (Brimonidine/Timolol) represents the percent changes in flow index after using topical brimonidine or timolol drops to lower eye pressure.

  5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan)

Study Arms (2)

Timolol

ACTIVE COMPARATOR

Timolol maleate 0.5% ophthalmic solution Instillation of one drop in each eye, once.

Drug: Timolol Maleate

Brimonidine

ACTIVE COMPARATOR

Brimonidine tartrate 0.2% Instillation of one drop in each eye, once.

Drug: Brimonidine Tartrate

Interventions

Timolol Maleate DRUG

Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation.

Also known as: Timolol

Timolol

Brimonidine Tartrate DRUG

Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation.

Also known as: Brimonidine

Brimonidine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of ocular hypertension, primary open angle glaucoma, or normal tension glaucoma in the study eye(s)
• Age 18-90
• Best corrected visual acuity of 20/60 or better

You may not qualify if:

• Current use of either brimonidine or timolol
• Other disease, ophthalmic or systemic, that is likely to significantly affect the OCT test in the study eye(s) including:
• More than moderate grade cataract that significantly reducing OCTA scan signal level
• Macular degeneration other than mild drusen or pigmentary changes
• Diabetic retinopathy other than mild background non proliferative retinopathy
• Prior or current macular edema
• Prior laser treatment to the retina
• Prior retinal detachment
• Prior central serous retinopathy
• Prior retinal vein or artery occlusion
• Prior inflammatory retinopathy or choroidopathy
• Keratoconus or other corneal ectasia
• Corneal scarring in central 4 mm
• Prior penetrating keratoplasty
• Ischemic optic neuropathy

Sponsors & Collaborators

• Wills Eye: lead
• Optovue: collaborator

Study Sites (1)

Glaucoma Research Center - Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Glaucoma; Low Tension Glaucoma; Glaucoma, Open-Angle

Interventions

Timolol; Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Limited sample size in this pilot study.

Results Point of Contact

• Title: Dr. Daniel Lee
• Organization: Wills Eye Hospital

daniellee@willseye.org

12159283197

Study Officials

• Daniel Lee, MD

  Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 26, 2017
• Study Start: July 10, 2017
• Primary Completion: December 31, 2018
• Study Completion: May 30, 2020
• Last Updated: December 31, 2020
• Results First Posted: December 31, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)