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Slow recruitment and lack of funding to expand to other sites.
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The purpose of this study is to determine whether fluoxetine, a selective serotonin reuptake inhibitor commonly used for depression, enhances visual recovery after an acute ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoxetine | Experimental | 20 mg fluoxetine capsule by mouth once daily for 90 days |
|
| Placebo | Placebo Comparator | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoxetine | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in the Bionocularly Averaged Perimetric Mean Deviation | 24-2 Humphrey perimetry was completed for each eye (Zeiss HFAIIi, Swedish Interactive Threshold Algorithm (SITA) Standard, size III white target, fixation enforced, corrected for near vision). The cutoff of a sensitivity of 10 dB to define sighted versus blind test locations was chosen. Perimetric mean deviation is a summary statistic calculated by measuring the deviation from the expected threshold value for stimulation at each point in the visual field and taking an average, with possible values ranging from +2 to -32 dB. | baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change in Field Points Tested | Visual field recovery is defined as an improvement of more than 6 decibels (dB) in the threshold required to elicit a response at each point in the Humphrey visual field. This is based on the unidirectional test-retest variability of less than 3 dB reported in the Humphrey Field Analyzer manual. The endpoint will be an improvement in threshold values at test locations spanning more than 10 degrees horizontally or 15 degrees vertically in the Humphrey visual field in both eyes at 6 months, based on the definition of visual improvement used by Zhang et al. in their natural history study of stroke patients with hemianopia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Strong Memorial Hospital | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16567709 | Background | Zhang X, Kedar S, Lynn MJ, Newman NJ, Biousse V. Natural history of homonymous hemianopia. Neurology. 2006 Mar 28;66(6):901-5. doi: 10.1212/01.wnl.0000203338.54323.22. | |
| 36166771 | Derived | Schneider CL, Prentiss EK, Busza A, Williams ZR, Mahon BZ, Sahin B. FLUORESCE: A Pilot Randomized Clinical Trial of Fluoxetine for Vision Recovery After Acute Ischemic Stroke. J Neuroophthalmol. 2023 Jun 1;43(2):237-242. doi: 10.1097/WNO.0000000000001654. Epub 2022 Jul 8. |
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5 participants were consented but 1 screen failed and 4 withdrew from the study before being randomized to an arm, received the intervention and before any data was collected.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluoxetine | 20 mg fluoxetine capsule by mouth once daily for 90 days Fluoxetine |
| FG001 | Placebo | Matching placebo Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluoxetine | 20 mg fluoxetine capsule by mouth once daily for 90 days Fluoxetine |
| BG001 | Placebo | Matching placebo Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Percent Change in the Bionocularly Averaged Perimetric Mean Deviation | 24-2 Humphrey perimetry was completed for each eye (Zeiss HFAIIi, Swedish Interactive Threshold Algorithm (SITA) Standard, size III white target, fixation enforced, corrected for near vision). The cutoff of a sensitivity of 10 dB to define sighted versus blind test locations was chosen. Perimetric mean deviation is a summary statistic calculated by measuring the deviation from the expected threshold value for stimulation at each point in the visual field and taking an average, with possible values ranging from +2 to -32 dB. | One participant in the placebo arm withdrew from the study after month 1 but was included in the analysis. | Posted | Mean | 95% Confidence Interval | percent change in dB | baseline to 6 months |
|
6 months
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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 | Fluoxetine | 20 mg fluoxetine capsule by mouth once daily for 90 days Fluoxetine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hemorrhagic transformation | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bogachan Sahin | University of Rochester | (585) 275-2530 | bogachan_sahin@urmc.rochester.edu |
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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 | Mar 15, 2016 | Aug 3, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 27, 2019 | Aug 3, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D006423 | Hemianopsia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Drug |
|
| 6 months |
| Number of Participants With >95% Recovery | Recovery is an improvement in the blind visual field. Participants were counted if the percentage of visual field that was blind was reduced by 95%. | 6 months |
| Functional Field Score | This is a measure of functional peripheral vision in patients with otherwise normal visual acuity. It is calculated from perimetric data. Scores of 75-110 indicate near-normal to normal vision, 55-70 moderate low vision, 35-50 severe low vision, 15-30 profound low vision, and less than 15 near to total blindness. Hemianopia is considered severe low vision. | 6 months |
| Percent Change in Mean Visual Function Questionnaire-25 Score | The VFQ-25 consists of a base set of 25 vision targeted questions representing 11 vision-related constructs: global vision rating, difficulty with near vision activities, difficulty with distance vision activities, limitations in social functioning due to vision, role limitations due to vision, dependency on others due to vision, mental health symptoms due to vision, driving difficulties, limitations with peripheral and color vision, and ocular pain. The scores range from 0-100 with higher scores indicating better functioning. | baseline to 6 months |
| Median Change in Patient Health Questionnaire-9 Score | This is a self-report inventory used as a screening and diagnostic tool for depression (Appendix F). The 9 items are based on the 9 diagnostic criteria for depression included in the Diagnostic and Statistical Manual of Mental Disorders IV. The scales ranges from 0-27 with higher scores indicating worse outcome. | baseline to 6 months |
| Median Modified Rankin Scale Score | This is a functional outcome measure widely used in stroke clinical trials, with a score of 0 indicating no disability, 6 indicating death, and scores of 2 or less generally accepted to indicate a favorable functional outcome. | 90 days |
| Post-stroke Changes in Cortical Visual Representation as Measured by Functional Magnetic Resonance Imaging | Functional magnetic resonance imaging is a high-resolution imaging technique that can be used to measure cortical visual representation and functional activity during visual tasks using blood oxygen level-dependent responses. In stroke patients, this technique can be used to characterize the degree and nature of peri-lesional remapping of regions of the blind visual field during post-stroke visual recovery. Standard retinotopic mapping procedures will be used to determine the number of voxels in the early visual cortex that represent information about stimuli presented in the blind field of each patient. | 6 months |
| Mean Percent Change in Post-stroke Retinal Nerve Fiber Layer Thickness | This will be measured by spectral domain optical coherence tomography. Optical coherence tomography is a method of using low-coherence interferometry to determine the echo time delay and magnitude of backscattered light reflected off an object of interest. This method can be used to scan through the layers of a structured tissue sample such as the retina with very high axial resolution (3 to 15 μm), providing images demonstrating 3D structure. | baseline to 6 months |
| 33230035 | Derived | Saionz EL, Feldon SE, Huxlin KR. Rehabilitation of cortically induced visual field loss. Curr Opin Neurol. 2021 Feb 1;34(1):67-74. doi: 10.1097/WCO.0000000000000884. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| 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 |
|
| Number of participants who received tissue plasminogen activator | Number | participants |
|
| Number of participants with diabetes | Number | participants |
|
| Number of participants with hypertension | Number | participants |
|
| OG001 | Placebo | Matching placebo Placebo |
|
|
| Secondary | Mean Percent Change in Field Points Tested | Visual field recovery is defined as an improvement of more than 6 decibels (dB) in the threshold required to elicit a response at each point in the Humphrey visual field. This is based on the unidirectional test-retest variability of less than 3 dB reported in the Humphrey Field Analyzer manual. The endpoint will be an improvement in threshold values at test locations spanning more than 10 degrees horizontally or 15 degrees vertically in the Humphrey visual field in both eyes at 6 months, based on the definition of visual improvement used by Zhang et al. in their natural history study of stroke patients with hemianopia. | One participant in the placebo arm withdrew from the study after month 1 but was included in the analysis. | Posted | Mean | 95% Confidence Interval | percent of visual field points tested | 6 months |
|
|
|
| Secondary | Number of Participants With >95% Recovery | Recovery is an improvement in the blind visual field. Participants were counted if the percentage of visual field that was blind was reduced by 95%. | One participant in the placebo arm withdrew from the study after month 1 but was included in the analysis. | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Functional Field Score | This is a measure of functional peripheral vision in patients with otherwise normal visual acuity. It is calculated from perimetric data. Scores of 75-110 indicate near-normal to normal vision, 55-70 moderate low vision, 35-50 severe low vision, 15-30 profound low vision, and less than 15 near to total blindness. Hemianopia is considered severe low vision. | Data was not collected for this outcome measure. | Posted | 6 months |
|
|
| Secondary | Percent Change in Mean Visual Function Questionnaire-25 Score | The VFQ-25 consists of a base set of 25 vision targeted questions representing 11 vision-related constructs: global vision rating, difficulty with near vision activities, difficulty with distance vision activities, limitations in social functioning due to vision, role limitations due to vision, dependency on others due to vision, mental health symptoms due to vision, driving difficulties, limitations with peripheral and color vision, and ocular pain. The scores range from 0-100 with higher scores indicating better functioning. | One participant in the placebo arm withdrew from the study after month 1 but was included in the analysis. | Posted | Mean | 95% Confidence Interval | percent change of units on a scale | baseline to 6 months |
|
|
|
| Secondary | Median Change in Patient Health Questionnaire-9 Score | This is a self-report inventory used as a screening and diagnostic tool for depression (Appendix F). The 9 items are based on the 9 diagnostic criteria for depression included in the Diagnostic and Statistical Manual of Mental Disorders IV. The scales ranges from 0-27 with higher scores indicating worse outcome. | One participant in the placebo arm withdrew from the study after month 1 but was included in the analysis. | Posted | Median | Inter-Quartile Range | score on a scale | baseline to 6 months |
|
|
|
| Secondary | Median Modified Rankin Scale Score | This is a functional outcome measure widely used in stroke clinical trials, with a score of 0 indicating no disability, 6 indicating death, and scores of 2 or less generally accepted to indicate a favorable functional outcome. | One participant in the placebo arm withdrew from the study after month 1 but was included in the analysis. | Posted | Median | Inter-Quartile Range | score on a scale | 90 days |
|
|
|
| Secondary | Post-stroke Changes in Cortical Visual Representation as Measured by Functional Magnetic Resonance Imaging | Functional magnetic resonance imaging is a high-resolution imaging technique that can be used to measure cortical visual representation and functional activity during visual tasks using blood oxygen level-dependent responses. In stroke patients, this technique can be used to characterize the degree and nature of peri-lesional remapping of regions of the blind visual field during post-stroke visual recovery. Standard retinotopic mapping procedures will be used to determine the number of voxels in the early visual cortex that represent information about stimuli presented in the blind field of each patient. | Data was not collected for this outcome measure. | Posted | 6 months |
|
|
| Secondary | Mean Percent Change in Post-stroke Retinal Nerve Fiber Layer Thickness | This will be measured by spectral domain optical coherence tomography. Optical coherence tomography is a method of using low-coherence interferometry to determine the echo time delay and magnitude of backscattered light reflected off an object of interest. This method can be used to scan through the layers of a structured tissue sample such as the retina with very high axial resolution (3 to 15 μm), providing images demonstrating 3D structure. | One participant in the placebo arm withdrew from the study after month 1 but was included in the analysis. | Posted | Mean | 95% Confidence Interval | percent change in microns | baseline to 6 months |
|
|
|
| 0 |
| 5 |
| 3 |
| 5 |
| 0 |
| 5 |
| EG001 | Placebo | Matching placebo Placebo | 0 | 7 | 3 | 7 | 0 | 7 |
| stroke | Vascular disorders | Systematic Assessment |
|
| transient ischemic attack | Vascular disorders | Systematic Assessment |
|
| seizure | Nervous system disorders | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D001766 | Blindness |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |