Fluoxetine for Visual Recovery After Ischemic Stroke (FLUORESCE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02737930|
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : August 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Stroke Visual Field Loss||Drug: Fluoxetine Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Fluoxetine for Visual Recovery After Ischemic Stroke|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
20 mg fluoxetine capsule by mouth once daily for 90 days
Placebo Comparator: Placebo
- Improvement in size of visual field deficit (degrees) [ Time Frame: 6 months ]Improvement at each point in the Humphrey visual field will be defined as a decrease of more than 6 decibels (dB) in the threshold required to elicit a response at that location. This is based on the unidirectional test-retest variability of less than 3 dB reported in the Humphrey Field Analyzer manual. The primary 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.
- Improvement in size of visual field deficit (square degrees) [ Time Frame: 6 months ]Improvement at each point in the Humphrey visual field will be defined as a decrease of more than 6 dB in the threshold required to elicit a response at that location, as described in Outcome 1. The area of improvement in the visual field deficit will be measured in square degrees across test locations showing at least a 6-dB decrease in threshold values.
- Improvement in parametric mean deviation [ Time Frame: 6 months ]Parametric 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.
- Functional field score [ Time Frame: 6 months ]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.
- Visual Function Questionnaire-25 score [ Time Frame: 6 months ]
- Patient Health Questionnaire-9 score [ Time Frame: 6 months ]
- Modified Rankin Scale score [ Time Frame: 90 days ]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.
- Post-stroke changes in cortical visual representation as measured by functional magnetic resonance imaging [ Time Frame: 6 months ]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.
- Post-stroke changes in retinal nerve fiber layer thickness [ Time Frame: 6 months ]This will be measured by spectral domain optical coherence tomography.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737930
|Contact: Bogachan Sahin, MD, PhD||(585) email@example.com|
|Contact: Ann M Leonhardt, NP||(585) firstname.lastname@example.org|