Acute Autoimmune Inflammatory Optic NeuritisACSONNCT03862313
Repetitive Transorbital Alternating Current Stimulation in Acute Autoimmune Optic Neuritis
A study testing active-rtACS treatment in people with Acute Autoimmune Inflammatory Optic Neuritis, run by University of Zurich at 1 site in Switzerland.
Trial summary
Optic neuritis (ON) is an acute inflammatory, demyelinating attack of the optic nerve that triggers neurodegeneration in the entire visual pathway; translating into visual dysfunction. Currently, no neuroprotective therapy with satisfying evidence can be offered to patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acute Autoimmune Inflammatory Optic Neuritis
- What is being tested?
- active-rtACS treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Oct 2019to 27 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants fulfilling all of the following inclusion criteria are eligible for the study:
- Informed Consent as documented by signature
- Participants are capable of giving informed consent
- Participant who have a good knowledge of German (patient information and consent must be understood)
- Patients, presenting with typical signs and symptoms suggestive of a first-ever episode of unilateral acute autoimmune, inflammatory, demyelinating ON, including idiopathic ON and ON suggestive of multiple sclerosis (MS) (typical clinically isolated syndrome, or with an established diagnosis of relapsing-remitting MS according to latest panel criteria and no better explanation)
- Patients with high-contrast visual acuity of ≤ 0.63 (decimal system) corresponding to a LogMAR value of ≥ 0.2 on the affected eye (assessed using a Snellen chart during clinical routine)
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- Patients presenting in clinics within 14 days of symptom onset
- In principle 18-50 year old female and male patients may be recruited. However, since the randomization of patients will be controlled for gender and participants will be enrolled one at a time on a continuous basis, the gender might become relevant late in the study (e.g. if the female block has already been fully recruited and only males might still be enrolled).
- Patients are receiving standard-of-care treatment for ON (cortisone therapy)
Who cannot join
- The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
- Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial
- Women who are pregnant or have the intention to become pregnant during the course of the study (For women who can get pregnant, pregnancy will be omitted using a pregnancy test when checking for inclusion and exclusion criteria. Patients will be informed that they must use contraception during the study)
- Patients with a previous clinical history of ON in the respective eye
- Patients with obvious retinal pathology other than that associated with ON
- Patients who are unable to perform the study assessments (e.g. OCT examination) because of a severe nystagmus (repetitive, uncontrolled eye movements causing unsteady fixation)
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- Patients with a recent eye surgery
- Patients with known anti-aquaporin-4- or myelin oligodendrocyte glycoprotein- antibody seropositivity
- Patients with contraindications to the class of device under study (for rtACS): implanted electronic devices, metallic artefacts in the head (excluding dentition), epilepsy, brain cancer, pregnancy, breastfeeding, increased intraocular pressure without appropriate treatment, arterial hypertension without appropriate treatment, skin irritations at intended positions of electrodes, cognitive deficits (unable to provide written informed consent or follow the instructions)
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Participation in another study with investigational drug/device within the 30 days preceding and during the present study
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Neurology and Department of Ophthalmology, University Hospital Zurich
Zurich, 8091
About this study
Official title: Assessing Repetitive Transorbital Alternating Current Stimulation in Acute Autoimmune Inflammatory Optic Neuritis Using the NextWave® 1.1 System: A Prospective, Randomized, Patient-blinded, Sham-controlled Pilot Study
Optic neuritis (ON) is an acute inflammatory, demyelinating attack of the optic nerve that triggers neurodegeneration in the entire visual pathway; translating into visual dysfunction. Currently, no neuroprotective therapy with satisfying evidence can be offered to patients. Repetitive transorbital alternating current stimulation (rtACS) is a methodology applied to electrically stimulate the retina and the optic nerve and is considered having neuroprotective- and restorative potential. The goal of this pilot study is to assess safety, tolerability and preliminary efficacy of rtACS as a treatment to improve visual functional as well as structural retinal outcomes in patients with a first-ever episode of autoimmune acute ON.
- Being tested
- active-rtACS treatment, sham-rtACS treatment
- Keywords
- optic neuritis, multiple sclerosis, repetitive transorbital alternating current stimulation, optical coherence tomography, low-contrast visual acuity
- Medical subject headings
- Optic Neuritis, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active-rtACS treatmentDevice
Also called NextWave® 1.1 system, EBS Technologies GmbH, Germany
For the active-rtACS treatment arm, a CE-certificated proprietary class IIa medical device will be used to apply transorbital symmetrical rectangular current pulses in bursts (NextWave® 1.1 system; EBS Technologies GmbH, Germany). The stimulation protocol will be patient-individualized, with a stimulation current strength of 125% of the phosphene threshold recorded during 5Hz stimulation and stimulation frequencies between the individual's EEG alpha frequency and their flicker fusion frequency.
sham-rtACS treatmentDevice
Also called NextWave® 1.1 system, EBS Technologies GmbH, Germany
For the sham-rtACS treatment arm, exactly the same medical device, setup, time schedule, etc. will be used as for the patients of the active-rtACS arm. However, sham-treated patients will receive no actual current stimulation during the therapy sessions.
| Study group | Role | What they receive |
|---|---|---|
| active-rtACS arm | Experimental | Active rtACS on 10 consecutive working days, in addition to standard-of-care corticosteroid treatment. Receives: Device: active-rtACS treatment |
| sham-rtACS arm | Sham comparator | Sham rtACS on 10 consecutive working days, in addition to standard-of-care corticosteroid treatment. Receives: Device: sham-rtACS treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary functional outcome measure will be low-contrast visual acuity [LogMAR] at 16 weeks (3 month follow-up) in ON eyes.
Measured: 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)
The primary structural outcome measure will be the mean change in macular ganglion cell and inner plexiform layer thickness [µm] of the affected ON eye at 16 weeks in comparison to baseline of the unaffected contralateral NON eye (pre-treatment).
Measured: Baseline (pre-treatment, i.e. 1 week after recruitment), 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)
The primary safety outcome measure will be the total number of adverse events during the entire study period
Measured: up to 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)
Secondary outcomes (15)
Low-contrast visual acuity [LogMAR] at 4 (post-treatment) weeks in ON eyes.
Measured: post-treatment (4 weeks after recruitment, i.e. one week after the last treatment day)
The mean change in macular ganglion cell and inner plexiform layer thickness [µm] of the affected ON eye at 4 weeks in comparison to baseline of the unaffected contralateral NON eye (pre-treatment).
Measured: Baseline (pre-treatment, i.e. 1 week after recruitment), post-treatment (4 weeks after recruitment, i.e. one week after the last treatment day)
High-contrast visual acuity [LogMAR] at 16 weeks (3 month follow-up) in ON eyes.
Measured: 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)
High-contrast visual acuity [LogMAR] at 4 weeks (post-treatment) in ON eyes.
Measured: post-treatment (4 weeks after recruitment, i.e. one week after the last treatment day)
Colour vision [tritan] at 16 weeks (3 month follow-up) in ON eyes.
Measured: 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)
Colour vision [tritan] at 4 weeks (post-treatment) in ON eyes.
Measured: post-treatment (4 weeks after recruitment, i.e. one week after the last treatment day)
Visual field testing [dB] at 16 weeks (3 month follow-up) in ON eyes.
Measured: 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)
Visual field testing [dB] at 4 weeks (post-treatment) in ON eyes.
Measured: post-treatment (4 weeks after recruitment, i.e. one week after the last treatment day)
Recovery of pattern-reversal visual evoked potential conduction velocity of the affected optic nerve [ms] compared to the intra-individual baseline of the unaffected optic nerve at 16 weeks (3 month follow-up).
Measured: Baseline (pre-treatment, i.e. 1 week after recruitment), 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)
Patient-reported vision-related quality of life assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) at 16 weeks (3 month follow-up).
The questionnaire contains the following 12 sub-scales: general health, general vision, ocular pain, near activities, distance activities, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, colour vision and peripheral vision. The mean VFQ-25 composite score (calculated as an unweighted average of responses to all items except for the general health sub-scale) and selected sub-scale scores will be analysed. Each sub-scale, and also the composite score, will be quantified with values between 0-100, with zero being the worst and 100 being the best.
Measured: 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)
Patient-reported vision-related quality of life assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) at 4 weeks (post-treatment).
The questionnaire contains the following 12 sub-scales: general health, general vision, ocular pain, near activities, distance activities, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, colour vision and peripheral vision. The mean VFQ-25 composite score (calculated as an unweighted average of responses to all items except for the general health sub-scale) and selected sub-scale scores will be analysed. Each sub-scale, and also the composite score, will be quantified with values between 0-100, with zero being the worst and 100 being the best.
Measured: post-treatment (4 weeks after recruitment, i.e. one week after the last treatment day)
The mean change in peripapillary retinal nerve fibre layer (pRNFL) thickness [µm] of the affected ON eye at 16 weeks (3 month follow-up) in comparison to baseline of the contralateral NON eye.
Measured: Baseline (pre-treatment, i.e. 1 week after recruitment), 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)
The mean change in peripapillary retinal nerve fibre layer (pRNFL) thickness [µm] of the affected ON eye at 4 weeks (post-treatment) in comparison to baseline of the contralateral NON eye.
Measured: Baseline (pre-treatment, i.e. 1 week after recruitment), post-treatment (4 weeks after recruitment, i.e. one week after the last treatment day)
The mean change in macular inner nuclear layer (INL) thickness [µm] of the affected ON eye at 16 weeks (3 month follow-up) in comparison to baseline of the contralateral NON eye.
Measured: Baseline (pre-treatment, i.e. 1 week after recruitment), 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)
The mean change in macular inner nuclear layer (INL) thickness [µm] of the affected ON eye at 4 (post-treatment) weeks in comparison to baseline of the contralateral NON eye.
Measured: Baseline (pre-treatment, i.e. 1 week after recruitment), post-treatment (4 weeks after recruitment, i.e. one week after the last treatment day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start14 Oct 2019
- Primary completion27 Dec 2019
- Study completion27 Dec 2019
Why it stopped: Primarily due to insufficient recruitment (n = 2 instead of n = 30), the study was prematurely discontinued for feasibility reasons. Neither any meaningful results on safety nor on efficacy can be reported.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Autoimmune Inflammatory Optic NeuritisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich, Swiss MS Society, Data Management, Clinical Trials Center, Zurich, Switzerland
- Responsible party
- Sponsor
- Investigators
- Andreas Lutterotti, Prof. Dr. med., Principal investigator, Neuroimmunology and Multiple Sclerosis Research, Department of Neurology, University Hospital Zurich and University of Zurich, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862313
- Sponsor's protocol ID
- 201802353
- Acronym
- ACSON
- Status last verified
- Mar 2021
- First submitted
- 14 Feb 2019
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Repetitive Transorbital Alternating Current Stimulation in Acute Autoimmune Inflammatory Optic Neuritis Using the NextWave® 1.1 System: A Prospective, Randomized, Patient-blinded, Sham-controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03862313
- Acronym / sponsor ID
- ACSON / 201802353
- Keywords
- optic neuritis, multiple sclerosis, repetitive transorbital alternating current stimulation, optical coherence tomography, low-contrast visual acuity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primarily due to insufficient recruitment (n = 2 instead of n = 30), the study was prematurely discontinued for feasibility reasons. Neither any meaningful results on safety nor on efficacy can be reported.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University Hospital, Zürich, Swiss MS Society, Data Management, Clinical Trials Center, Zurich, Switzerland
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 27 Dec 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Optic neuritis (ON) is an acute inflammatory, demyelinating attack of the optic nerve that triggers neurodegeneration in the entire visual pathway; translating into visual dysfunction. Currently, no neuroprotective therapy with satisfying evidence can be offered to patients. Repetitive transorbital alternating current stimulation (rtACS) is a methodology applied to electrically stimulate the retina and the optic nerve and is considered having neuroprotective- and restorative potential. The goal of this pilot study is to assess safety, tolerability and preliminary efficacy of rtACS as a treatment to improve visual functional as well as structural retinal outcomes in patients with a first-ever episode of autoimmune acute ON.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active-rtACS arm | Experimental | Device: active-rtACS treatmentActive rtACS on 10 consecutive working days, in addition to standard-of-care corticosteroid treatment. |
| sham-rtACS arm | Sham comparator | Device: sham-rtACS treatmentSham rtACS on 10 consecutive working days, in addition to standard-of-care corticosteroid treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Participants fulfilling all of the following inclusion criteria are eligible for the study:
- Informed Consent as documented by signature
- Participants are capable of giving informed consent
- Participant who have a good knowledge of German (patient information and consent must be understood)
- Patients, presenting with typical signs and symptoms suggestive of a first-ever episode of unilateral acute autoimmune, inflammatory, demyelinating ON, including idiopathic ON and ON suggestive of multiple sclerosis (MS) (typical clinically isolated syndrome, or with an established diagnosis of relapsing-remitting MS according to latest panel criteria and no better explanation)
Key exclusion criteria (14 listed)
- The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
- Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial
- Women who are pregnant or have the intention to become pregnant during the course of the study (For women who can get pregnant, pregnancy will be omitted using a pregnancy test when checking for inclusion and exclusion criteria. Patients will be informed that they must use contraception during the study)
- Patients with a previous clinical history of ON in the respective eye
- Patients with obvious retinal pathology other than that associated with ON
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active-rtACS treatmentAlso: NextWave® 1.1 system, EBS Technologies GmbH, GermanyFor the active-rtACS treatment arm, a CE-certificated proprietary class IIa medical device will be used to apply transorbital symmetrical rectangular current pulses in bursts (NextWave® 1.1 system; EBS Technologies GmbH, Germany). The stimulation protocol will be patient-individualized, with a stimulation current strength of 125% of the phosphene threshold recorded during 5Hz stimulation and stimulation frequencies between the individual's EEG alpha frequency and their flicker fusion frequency. | Device | active-rtACS arm |
| sham-rtACS treatmentAlso: NextWave® 1.1 system, EBS Technologies GmbH, GermanyFor the sham-rtACS treatment arm, exactly the same medical device, setup, time schedule, etc. will be used as for the patients of the active-rtACS arm. However, sham-treated patients will receive no actual current stimulation during the therapy sessions. | Device | sham-rtACS arm |
Primary outcome
The primary functional outcome measure will be low-contrast visual acuity [LogMAR] at 16 weeks (3 month follow-up) in ON eyes.
Time frame: 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)
The primary structural outcome measure will be the mean change in macular ganglion cell and inner plexiform layer thickness [µm] of the affected ON eye at 16 weeks in comparison to baseline of the unaffected contralateral NON eye (pre-treatment).
Time frame: Baseline (pre-treatment, i.e. 1 week after recruitment), 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)
The primary safety outcome measure will be the total number of adverse events during the entire study period
Time frame: up to 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)
15 secondary outcomes
Low-contrast visual acuity [LogMAR] at 4 (post-treatment) weeks in ON eyes.
Time frame: post-treatment (4 weeks after recruitment, i.e. one week after the last treatment day)
The mean change in macular ganglion cell and inner plexiform layer thickness [µm] of the affected ON eye at 4 weeks in comparison to baseline of the unaffected contralateral NON eye (pre-treatment).
Time frame: Baseline (pre-treatment, i.e. 1 week after recruitment), post-treatment (4 weeks after recruitment, i.e. one week after the last treatment day)
High-contrast visual acuity [LogMAR] at 16 weeks (3 month follow-up) in ON eyes.
Time frame: 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)
High-contrast visual acuity [LogMAR] at 4 weeks (post-treatment) in ON eyes.
Time frame: post-treatment (4 weeks after recruitment, i.e. one week after the last treatment day)
Colour vision [tritan] at 16 weeks (3 month follow-up) in ON eyes.
Time frame: 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)
Colour vision [tritan] at 4 weeks (post-treatment) in ON eyes.
Time frame: post-treatment (4 weeks after recruitment, i.e. one week after the last treatment day)
Visual field testing [dB] at 16 weeks (3 month follow-up) in ON eyes.
Time frame: 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)
Visual field testing [dB] at 4 weeks (post-treatment) in ON eyes.
Time frame: post-treatment (4 weeks after recruitment, i.e. one week after the last treatment day)
Recovery of pattern-reversal visual evoked potential conduction velocity of the affected optic nerve [ms] compared to the intra-individual baseline of the unaffected optic nerve at 16 weeks (3 month follow-up).
Time frame: Baseline (pre-treatment, i.e. 1 week after recruitment), 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)
Patient-reported vision-related quality of life assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) at 16 weeks (3 month follow-up).
Time frame: 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)
Patient-reported vision-related quality of life assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) at 4 weeks (post-treatment).
Time frame: post-treatment (4 weeks after recruitment, i.e. one week after the last treatment day)
The mean change in peripapillary retinal nerve fibre layer (pRNFL) thickness [µm] of the affected ON eye at 16 weeks (3 month follow-up) in comparison to baseline of the contralateral NON eye.
Time frame: Baseline (pre-treatment, i.e. 1 week after recruitment), 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)
The mean change in peripapillary retinal nerve fibre layer (pRNFL) thickness [µm] of the affected ON eye at 4 weeks (post-treatment) in comparison to baseline of the contralateral NON eye.
Time frame: Baseline (pre-treatment, i.e. 1 week after recruitment), post-treatment (4 weeks after recruitment, i.e. one week after the last treatment day)
The mean change in macular inner nuclear layer (INL) thickness [µm] of the affected ON eye at 16 weeks (3 month follow-up) in comparison to baseline of the contralateral NON eye.
Time frame: Baseline (pre-treatment, i.e. 1 week after recruitment), 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)
The mean change in macular inner nuclear layer (INL) thickness [µm] of the affected ON eye at 4 (post-treatment) weeks in comparison to baseline of the contralateral NON eye.
Time frame: Baseline (pre-treatment, i.e. 1 week after recruitment), post-treatment (4 weeks after recruitment, i.e. one week after the last treatment day)
Results and safety
The study was stopped early (reason given: Primarily due to insufficient recruitment (n = 2 instead of n = 30), the study was prematurely discontinued for feasibility reasons. Neither any meaningful results on safety nor on efficacy can be reported.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Lutterotti, Prof. Dr. med. principal investigator
Neuroimmunology and Multiple Sclerosis Research, Department of Neurology, University Hospital Zurich and University of Zurich, Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active-rtACS treatment in people with Acute Autoimmune Inflammatory Optic Neuritis, run by University of Zurich at 1 site in Switzerland.
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 9 inclusion and 14 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 30 Mar 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 Switzerland. 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.
Are results available for this study?
The study was stopped early (reason given: Primarily due to insufficient recruitment (n = 2 instead of n = 30), the study was prematurely discontinued for feasibility reasons. Neither any meaningful results on safety nor on efficacy can be reported.). Results are not available in the source record.
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?
The primary functional outcome measure will be low-contrast visual acuity [LogMAR] at 16 weeks (3 month follow-up) in ON eyes. (time frame: 3 month follow-up (16 weeks after recruitment, i.e. 3 months after the last treatment day)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2021.