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Acute StrokePhase 2FLUORESCENCT02737930

Fluoxetine for Visual Recovery After Ischemic Stroke

A Phase 2 study testing Fluoxetine in people with Acute Stroke and Visual Field Loss, run by Bogachan Sahin at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Acute Stroke, Visual Field Loss
What is being tested?
Fluoxetine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
1 siteUnited States
Study dates
May 2016to Aug 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • MRI-confirmed acute ischemic stroke resulting in an isolated homonymous visual field loss.

Who cannot join

  • Known hypersensitivity to fluoxetine or other selective serotonin reuptake inhibitors
  • National Institutes of Health Stroke Scale score greater than 5
  • Premorbid modified Rankin Scale score greater than 2
  • Premorbid monocular or binocular visual field deficits
  • Premorbid retinopathy or optic neuropathy
  • Premorbid depression
Show all 19Show fewer
  • History of cognitive impairment, dementia, or neurodegenerative disorder
  • History of seizure disorder
  • History of mania or hypomania
  • History of hyponatremia
  • History of angle-closure glaucoma or elevated intraocular pressure
  • Current alcohol abuse or impaired liver function
  • Current use of an antidepressant medication
  • Current use of a medication likely to have an adverse interaction with fluoxetine
  • Current use of a medication likely to impair post-stroke recovery
  • Contraindication to MRI
  • Pregnancy or lactation
  • Hemorrhagic transformation of the index stroke, resulting in mass effect
  • Enrollment in another clinical trial at the time of the index stroke

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Strong Memorial Hospital

    Rochester, New York, 14642

Other trials in United States

About this study

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.

Being tested
Fluoxetine, Placebo
Keywords
Acute ischemic stroke, Homonymous hemianopia, Homonymous quadrantanopia, Visual field loss, Post-stroke recovery, Fluoxetine, Selective serotonin reuptake inhibitor
Medical subject headings
Stroke, Ischemic Stroke, Hemianopsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FluoxetineDrug

    Also called Prozac, Sarafem

  • PlaceboDrug

Study groups in NCT02737930
Study groupRoleWhat they receive
FluoxetineExperimental20 mg fluoxetine capsule by mouth once daily for 90 days
Receives: Drug: Fluoxetine
PlaceboPlacebo comparatorMatching placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline to 6 months

Secondary outcomes (8)

  1. 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.

    Measured: 6 months

  2. 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%.

    Measured: 6 months

  3. 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.

    Measured: 6 months

  4. 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.

    Measured: baseline to 6 months

  5. 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.

    Measured: baseline to 6 months

  6. 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.

    Measured: 90 days

  7. 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.

    Measured: 6 months

  8. 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.

    Measured: baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionAug 2020
  4. Study completionAug 2020

Why it stopped: Slow recruitment and lack of funding to expand to other sites.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02737930
Sponsor's protocol ID
RSRB00058133
Acronym
FLUORESCE
Status last verified
Sep 2021
First submitted
1 Apr 2016
Last updated
13 Oct 2021
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 16567709

  • 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.

    PubMed 36166771

  • 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.

    PubMed 33230035

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fluoxetine in people with Acute Stroke and Visual Field Loss, run by Bogachan Sahin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in the Bionocularly Averaged Perimetric Mean Deviation (time frame: baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02737930, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021; AzTrials last refreshed its copy on 31 Oct 2026.

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