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| Name | Class |
|---|---|
| Optovue | INDUSTRY |
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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.
Reduction of intraocular pressure (IOP) with topical antihypertensive medications is the mainstay of initial treatment in patients with OHTN, POAG, and NTG. Many patients, however, continue to experience disease progression despite IOP reduction. Alternative mechanisms of neurodegeneration, including vascular dysregulation and structural susceptibility of the lamina cribrosa, have been proposed as important mechanisms in progression, particularly in cases of NTG.
Prior studies have also found decreased calculated mean ocular perfusion with the use of timolol compared to other antiglaucoma medications in patients with normal tension glaucoma. Visual field deterioration has also been shown to be associated with systemic nocturnal arterial hypotension in patients with NTG, POAG, and after anterior ischemic optic neuropathy. The use of ophthalmic topical beta-blockers has been shown to lower nocturnal diastolic blood pressure and heart rate. Thus, topical beta blockers are often avoided in the treatment of NTG due to the potential risk of reduced optic nerve head perfusion
Studies evaluating optic nerve head (ONH) perfusion are limited. Earlier studies evaluated indirect measurements, such as calculated mean ocular perfusion pressure or systemic hypotension, as indications of optic nerve hypoperfusion. Direct measurements of ocular perfusion have been attempted using retrobulbar color Doppler imaging, which demonstrated decreased short posterior ciliary artery flow velocity in patients with glaucomatous visual field progression. This technique, however, has yielded inconsistent results in other studies, and is only capable of detecting gross changes to ocular blood flow.
Optical Coherence Tomography Angiography (OCTA) is a novel technique first introduced in 2014 using a custom swept-source OCT system.No studies currently exist to evaluate the effects of antiglaucoma medications on peripapillary blood flow using OCTA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Timolol | Active Comparator | Timolol maleate 0.5% ophthalmic solution Instillation of one drop in each eye, once. |
|
| Brimonidine | Active Comparator | Brimonidine tartrate 0.2% Instillation of one drop in each eye, once. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timolol Maleate | Drug | Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Lee, MD | Wills Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glaucoma Research Center - Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Timolol | Timolol maleate 0.5% ophthalmic solution Instillation of one drop in each eye, once. Timolol Maleate: Instillation of one drop in each eye, one-time. Obtaining optical coherence tomography (OCT) angiography scans after 2 hours of instillation. |
| FG001 | Brimonidine | Brimonidine tartrate 0.2% Instillation of one drop in each eye, once. Brimonidine Tartrate: Instillation of one drop in each eye, one-time. Obtaining optical coherence tomography (OCT) angiography scans after 2 hours of instillation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Timolol | Timolol maleate 0.5% ophthalmic solution Instillation of one drop in each eye, once. Timolol Maleate: Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation. |
| BG001 | Brimonidine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percent change | 5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan) |
|
4 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Timolol | Timolol maleate 0.5% ophthalmic solution Instillation of one drop in each eye, once. Timolol Maleate: Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation. |
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Limited sample size in this pilot study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Lee | Wills Eye Hospital | 12159283197 | daniellee@willseye.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2017 | Jul 29, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D057066 | Low Tension Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D009901 | Optic Nerve Diseases |
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| ID | Term |
|---|---|
| D013999 | Timolol |
| D000068438 | Brimonidine Tartrate |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Brimonidine Tartrate | Drug | Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation. |
|
|
| 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) |
Brimonidine tartrate 0.2% Instillation of one drop in each eye, once. Brimonidine Tartrate: Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Glaucoma type | Patients diagnosed with primary open angle glaucoma (POAG), normal tension glaucoma (NTG) or ocular hypertension (OHTN), with a best corrected visual acuity of at least 20/60 were invited to participate. | Count of Participants | Participants |
|
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Timolol eye drops to lower eye pressure before . |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | percent change | 5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan) |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | percent change | 5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan) |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | percent change | 5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan) |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Percent change | 5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan) |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | percent change | 5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan) |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Brimonidine | Brimonidine tartrate 0.2% Instillation of one drop in each eye, once. Brimonidine Tartrate: Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D020005 |
| Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| NTG |
|
| OHTN |
|
| POAG |
|
| NTG |
|
| OHTN |
|
| POAG |
|
| NTG |
|
| OHTN |
|
| POAG |
|
| NTG |
|
| OHTN |
|
| POAG |
|
| NTG |
|
| OHTN |
|