Assessment of NfL and GFAP Levels, Atrophy of the Macula GCC by OCT and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in MS Patients (NFL OCT)
Assessment of Serum Neurofilament-light Chain (NfL) and Glial Fibrillary Acidic Protein (GFAP) Levels, Atrophy of the Macular Ganglion Cell Complex (GCC) by Optical Coherence Tomography (OCT) and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in Multiple Sclerosis Patients
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Locations
-
-
-
Nîmes, France, 30029
- CHU de Nîmes
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- The patient has been correctly informed.
- The patient must have given their informed and signed consent.
- The patient must be insured or beneficiary of a health insurance plan.
- The patient is at least (≥)18 years old.
The patient has experienced a CIS, has currently a RRMS or progressive MS with:
- Less than 10 years of disease duration;
- With or without DMD;
- EDSS score 0 - 7.0.
Exclusion Criteria:
- The patient is in an exclusion period determined by a previous study.
- The patient is under judicial protection.
- The patient refuses to sign the consent.
- It is impossible to correctly inform the patient (Inability to understand the study, language problem).
- The patient is pregnant or breast-feeding.
- Patient has a bilateral optic neuritis or other significant ophthalmological antecedent.
- Patient with MRI contra-indications.
- patient has a contraindication to gadolinium injection
- The patient has bilateral optic neuritis or other significant ophthalmological antecedent
- Patient is having a relapse or has had a relapse in the last 3 months
- The patient has a severe psychiatric illness
- The patient has severe chronic alcoholism
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
MS patients
|
Sagittal T2 Sagittal T1 with Gadolinium injection
spectral-domain high definition optical coherence tomography
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in serum Neurofilament Light Chain serum levels since baseline
Time Frame: Baseline; 1 year
|
pg/mL; measured by digital ELISA
|
Baseline; 1 year
|
|
Change in serum Glial Fibrillary Acidic Protein (GFAP) serum levels since baseline
Time Frame: Baseline; 1 year
|
pg/mL; measured by digital ELISA
|
Baseline; 1 year
|
|
Change in Ganglion Cell Complex thickness since baseline
Time Frame: Baseline; 1 year
|
Measured by Optical Coherence Tomography
|
Baseline; 1 year
|
|
Change in whole brain volume since baseline
Time Frame: Baseline; 1 year
|
Assessed by MRI
|
Baseline; 1 year
|
|
Expanded Disability Status Scale
Time Frame: Baseline
|
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
|
Baseline
|
|
Expanded Disability Status Scale
Time Frame: 3 years
|
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
|
3 years
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Expanded Disability Status Scale
Time Frame: 3 years
|
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
|
3 years
|
|
Whole brain volume
Time Frame: Inclusion
|
assessed by MRI
|
Inclusion
|
|
Whole brain volume
Time Frame: 6 Months
|
assessed by MRI
|
6 Months
|
|
Whole brain volume
Time Frame: 1 Year
|
assessed by MRI
|
1 Year
|
|
Whole brain volume
Time Frame: 2 years
|
assessed by MRI
|
2 years
|
|
Whole brain volume
Time Frame: 3 Years
|
assessed by MRI
|
3 Years
|
|
Whole brain volume
Time Frame: 4 Years
|
assessed by MRI
|
4 Years
|
|
Whole brain volume
Time Frame: 5 years
|
assessed by MRI
|
5 years
|
|
Whole brain volume
Time Frame: any relapse (max 5 years)
|
assessed by MRI
|
any relapse (max 5 years)
|
|
Expanded Disability Status Scale
Time Frame: Inclusion
|
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
|
Inclusion
|
|
Expanded Disability Status Scale
Time Frame: 6 Months
|
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
|
6 Months
|
|
Expanded Disability Status Scale
Time Frame: 1 year
|
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
|
1 year
|
|
Expanded Disability Status Scale
Time Frame: 18 months
|
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
|
18 months
|
|
Expanded Disability Status Scale
Time Frame: 2 years
|
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
|
2 years
|
|
Expanded Disability Status Scale
Time Frame: 2.5 years
|
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
|
2.5 years
|
|
Expanded Disability Status Scale
Time Frame: 3.5 years
|
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
|
3.5 years
|
|
Expanded Disability Status Scale
Time Frame: 4 years
|
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
|
4 years
|
|
Expanded Disability Status Scale
Time Frame: 4.5 years
|
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
|
4.5 years
|
|
Expanded Disability Status Scale
Time Frame: 5 years
|
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
|
5 years
|
|
Expanded Disability Status Scale
Time Frame: Any relapse (Maximum 5 years)
|
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
|
Any relapse (Maximum 5 years)
|
|
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
Time Frame: Inclusion
|
assessed by Optical Coherence Tomography
|
Inclusion
|
|
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
Time Frame: 6 Months
|
assessed by Optical Coherence Tomography
|
6 Months
|
|
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
Time Frame: 1 Year
|
assessed by Optical Coherence Tomography
|
1 Year
|
|
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
Time Frame: 18 Months
|
assessed by Optical Coherence Tomography
|
18 Months
|
|
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
Time Frame: 2 years
|
assessed by Optical Coherence Tomography
|
2 years
|
|
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
Time Frame: 3 Years
|
assessed by Optical Coherence Tomography
|
3 Years
|
|
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
Time Frame: 4 Years
|
assessed by Optical Coherence Tomography
|
4 Years
|
|
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
Time Frame: 5 Years
|
assessed by Optical Coherence Tomography
|
5 Years
|
|
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
Time Frame: Any relapse (maximum 5 Years)
|
assessed by Optical Coherence Tomography
|
Any relapse (maximum 5 Years)
|
|
Gadolinium-enhanced lesions
Time Frame: Inclusion
|
assessed by MRI
|
Inclusion
|
|
Gadolinium-enhanced lesions
Time Frame: 6 Months
|
assessed by MRI
|
6 Months
|
|
Gadolinium-enhanced lesions
Time Frame: 1 Year
|
assessed by MRI
|
1 Year
|
|
Gadolinium-enhanced lesions
Time Frame: 2 years
|
assessed by MRI
|
2 years
|
|
Gadolinium-enhanced lesions
Time Frame: 3 Years
|
assessed by MRI
|
3 Years
|
|
Gadolinium-enhanced lesions
Time Frame: 4 Years
|
assessed by MRI
|
4 Years
|
|
Gadolinium-enhanced lesions
Time Frame: 5 Years
|
assessed by MRI
|
5 Years
|
|
Gadolinium-enhanced lesions
Time Frame: Any relapse (Maximum 5 Years)
|
assessed by MRI
|
Any relapse (Maximum 5 Years)
|
|
T2 lesion volume,
Time Frame: Inclusion
|
assessed by MRI
|
Inclusion
|
|
T2 lesion volume,
Time Frame: 6 Months
|
assessed by MRI
|
6 Months
|
|
T2 lesion volume,
Time Frame: 1 Year
|
assessed by MRI
|
1 Year
|
|
T2 lesion volume,
Time Frame: 2 years
|
assessed by MRI
|
2 years
|
|
T2 lesion volume,
Time Frame: 3 Years
|
assessed by MRI
|
3 Years
|
|
T2 lesion volume,
Time Frame: 4 Years
|
assessed by MRI
|
4 Years
|
|
T2 lesion volume,
Time Frame: 5 years
|
assessed by MRI
|
5 years
|
|
T2 lesion volume,
Time Frame: Any relapse (maximum 5 years)
|
assessed by MRI
|
Any relapse (maximum 5 years)
|
|
Grey matter atrophy
Time Frame: Inclusion
|
assessed by MRI
|
Inclusion
|
|
Grey matter atrophy
Time Frame: 6 Months
|
assessed by MRI
|
6 Months
|
|
Grey matter atrophy
Time Frame: 1 Year
|
assessed by MRI
|
1 Year
|
|
Grey matter atrophy
Time Frame: 2 years
|
assessed by MRI
|
2 years
|
|
Grey matter atrophy
Time Frame: 3 Years
|
assessed by MRI
|
3 Years
|
|
Grey matter atrophy
Time Frame: 4 Years
|
assessed by MRI
|
4 Years
|
|
Grey matter atrophy
Time Frame: 5 Years
|
assessed by MRI
|
5 Years
|
|
Grey matter atrophy
Time Frame: Any relapse (maximum 5 Years)
|
assessed by MRI
|
Any relapse (maximum 5 Years)
|
|
White matter atrophy
Time Frame: Inclusion
|
assessed by MRI
|
Inclusion
|
|
White matter atrophy
Time Frame: 6 Months
|
assessed by MRI
|
6 Months
|
|
White matter atrophy
Time Frame: 1 Year
|
assessed by MRI
|
1 Year
|
|
White matter atrophy
Time Frame: 2 years
|
assessed by MRI
|
2 years
|
|
White matter atrophy
Time Frame: 3 Years
|
assessed by MRI
|
3 Years
|
|
White matter atrophy
Time Frame: 4 Years
|
assessed by MRI
|
4 Years
|
|
White matter atrophy
Time Frame: 5 years
|
assessed by MRI
|
5 years
|
|
White matter atrophy
Time Frame: Any relapse (maximum 5 years)
|
assessed by MRI
|
Any relapse (maximum 5 years)
|
|
Thalamic atrophy
Time Frame: Inclusion
|
assessed by MRI
|
Inclusion
|
|
Thalamic atrophy
Time Frame: 6 Months
|
assessed by MRI
|
6 Months
|
|
Thalamic atrophy
Time Frame: 1 Year
|
assessed by MRI
|
1 Year
|
|
Thalamic atrophy
Time Frame: 2 years
|
assessed by MRI
|
2 years
|
|
Thalamic atrophy
Time Frame: 3 Years
|
assessed by MRI
|
3 Years
|
|
Thalamic atrophy
Time Frame: 4 Years
|
assessed by MRI
|
4 Years
|
|
Thalamic atrophy
Time Frame: 5 years
|
assessed by MRI
|
5 years
|
|
Thalamic atrophy
Time Frame: Any relapse (maximum 5 years)
|
assessed by MRI
|
Any relapse (maximum 5 years)
|
|
Disease modifying drugs classification
Time Frame: Inclusion
|
Drug class (1st, 2nd or 3rd line)
|
Inclusion
|
|
Disease modifying drugs classification
Time Frame: until end of study (5 years)
|
Drug class (1st, 2nd or 3rd line)
|
until end of study (5 years)
|
|
serum NfL levels
Time Frame: 6 Months
|
pg/mL; measured by digital ELISA
|
6 Months
|
|
serum GFAP levels
Time Frame: 6 Months
|
pg/mL; measured by digital ELISA
|
6 Months
|
|
serum NfL levels
Time Frame: 2 years
|
pg/mL; measured by digital ELISA
|
2 years
|
|
serum GFAP levels
Time Frame: 2 years
|
pg/mL; measured by digital ELISA
|
2 years
|
|
serum NfL levels
Time Frame: 3 years
|
pg/mL; measured by digital ELISA
|
3 years
|
|
serum GFAP levels
Time Frame: 3 years
|
pg/mL; measured by digital ELISA
|
3 years
|
|
serum NfL levels
Time Frame: 4 years
|
pg/mL; measured by digital ELISA
|
4 years
|
|
serum GFAP levels
Time Frame: 4 years
|
pg/mL; measured by digital ELISA
|
4 years
|
|
serum NfL levels
Time Frame: 5 years
|
pg/mL; measured by digital ELISA
|
5 years
|
|
serum GFAP levels
Time Frame: 5 years
|
pg/mL; measured by digital ELISA
|
5 years
|
|
serum NfL levels
Time Frame: Any relapse (maximum 5 years)
|
pg/mL; measured by digital ELISA
|
Any relapse (maximum 5 years)
|
|
serum GFAP levels
Time Frame: Any relapse (maximum 5 years)
|
pg/mL; measured by digital ELISA
|
Any relapse (maximum 5 years)
|
|
Multiple Sclerosis Functional Composite
Time Frame: Inclusion
|
21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT)
|
Inclusion
|
|
Multiple Sclerosis Functional Composite
Time Frame: 6 Months
|
21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT)
|
6 Months
|
|
Multiple Sclerosis Functional Composite
Time Frame: 1 Year
|
21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT)
|
1 Year
|
|
Multiple Sclerosis Functional Composite
Time Frame: 2 years
|
21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT)
|
2 years
|
|
Multiple Sclerosis Functional Composite
Time Frame: 3 years
|
21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT)
|
3 years
|
|
Multiple Sclerosis Functional Composite
Time Frame: 4 years
|
21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT)
|
4 years
|
|
Multiple Sclerosis Functional Composite
Time Frame: 5 years
|
21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT)
|
5 years
|
|
Multiple Sclerosis Functional Composite
Time Frame: Any relapse (maximum 5 years)
|
21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT)
|
Any relapse (maximum 5 years)
|
|
Time to walk 100 meters
Time Frame: Inclusion
|
Seconds
|
Inclusion
|
|
Time to walk 100 meters
Time Frame: 6 Months
|
Seconds
|
6 Months
|
|
Time to walk 100 meters
Time Frame: 1 Year
|
Seconds
|
1 Year
|
|
Time to walk 100 meters
Time Frame: 2 years
|
Seconds
|
2 years
|
|
Time to walk 100 meters
Time Frame: 3 years
|
Seconds
|
3 years
|
|
Time to walk 100 meters
Time Frame: 4 years
|
Seconds
|
4 years
|
|
Time to walk 100 meters
Time Frame: 5 years
|
Seconds
|
5 years
|
|
Time to walk 100 meters
Time Frame: Any relapse (maximum 5 years)
|
Seconds
|
Any relapse (maximum 5 years)
|
|
2 Minute walking distance
Time Frame: Inclusion
|
Meters
|
Inclusion
|
|
2 Minute walking distance
Time Frame: 6 Months
|
Meters
|
6 Months
|
|
2 Minute walking distance
Time Frame: 1 Year
|
Meters
|
1 Year
|
|
2 Minute walking distance
Time Frame: 2 years
|
Meters
|
2 years
|
|
2 Minute walking distance
Time Frame: 3 years
|
Meters
|
3 years
|
|
2 Minute walking distance
Time Frame: 4 years
|
Meters
|
4 years
|
|
2 Minute walking distance
Time Frame: 5 years
|
Meters
|
5 years
|
|
2 Minute walking distance
Time Frame: Any relapse (maximum 5 years)
|
Meters
|
Any relapse (maximum 5 years)
|
|
Cognitive Impairment
Time Frame: Inclusion
|
Symbol Digit Modalities Test
|
Inclusion
|
|
Cognitive Impairment
Time Frame: 6 months
|
Symbol Digit Modalities Test
|
6 months
|
|
Cognitive Impairment
Time Frame: 1 Year
|
Symbol Digit Modalities Test
|
1 Year
|
|
Cognitive Impairment
Time Frame: 2 years
|
Symbol Digit Modalities Test
|
2 years
|
|
Cognitive Impairment
Time Frame: 3 years
|
Symbol Digit Modalities Test
|
3 years
|
|
Cognitive Impairment
Time Frame: 4 years
|
Symbol Digit Modalities Test
|
4 years
|
|
Cognitive Impairment
Time Frame: 5 years
|
Symbol Digit Modalities Test
|
5 years
|
|
Cognitive Impairment
Time Frame: Any relapse (maximum 5 years)
|
Symbol Digit Modalities Test
|
Any relapse (maximum 5 years)
|
|
Cognitive evaluation
Time Frame: Inclusion
|
Brief International Cognitive Assessment for Multiple Sclerosis
|
Inclusion
|
|
Cognitive evaluation
Time Frame: 6 Months
|
Brief International Cognitive Assessment for Multiple Sclerosis
|
6 Months
|
|
Cognitive evaluation
Time Frame: 1 Year
|
Brief International Cognitive Assessment for Multiple Sclerosis
|
1 Year
|
|
Cognitive evaluation
Time Frame: 2 years
|
Brief International Cognitive Assessment for Multiple Sclerosis
|
2 years
|
|
Cognitive evaluation
Time Frame: 3 years
|
Brief International Cognitive Assessment for Multiple Sclerosis
|
3 years
|
|
Cognitive evaluation
Time Frame: 4 years
|
Brief International Cognitive Assessment for Multiple Sclerosis
|
4 years
|
|
Cognitive evaluation
Time Frame: 5 years
|
Brief International Cognitive Assessment for Multiple Sclerosis
|
5 years
|
|
Cognitive evaluation
Time Frame: Any relapse (maximum 5 years)
|
Brief International Cognitive Assessment for Multiple Sclerosis
|
Any relapse (maximum 5 years)
|
|
Health-related quality of life
Time Frame: Inclusion
|
EQ-5D-5L
|
Inclusion
|
|
Health-related quality of life
Time Frame: 6 Months
|
EQ-5D-5L
|
6 Months
|
|
Health-related quality of life
Time Frame: 1 Year
|
EQ-5D-5L
|
1 Year
|
|
Health-related quality of life
Time Frame: 2 years
|
EQ-5D-5L
|
2 years
|
|
Health-related quality of life
Time Frame: 3 years
|
EQ-5D-5L
|
3 years
|
|
Health-related quality of life
Time Frame: 4 years
|
EQ-5D-5L
|
4 years
|
|
Health-related quality of life
Time Frame: 5 years
|
EQ-5D-5L
|
5 years
|
|
Health-related quality of life
Time Frame: Any relapse (maximum 5 years)
|
EQ-5D-5L
|
Any relapse (maximum 5 years)
|
|
Impact of MS on daily life
Time Frame: Inclusion
|
Multiple Sclerosis Impact Scale (MSIS-29)
|
Inclusion
|
|
Impact of MS on daily life
Time Frame: 6 Months
|
Multiple Sclerosis Impact Scale (MSIS-29)
|
6 Months
|
|
Impact of MS on daily life
Time Frame: 1 Year
|
Multiple Sclerosis Impact Scale (MSIS-29)
|
1 Year
|
|
Impact of MS on daily life
Time Frame: 2 years
|
Multiple Sclerosis Impact Scale (MSIS-29)
|
2 years
|
|
Impact of MS on daily life
Time Frame: 3 years
|
Multiple Sclerosis Impact Scale (MSIS-29)
|
3 years
|
|
Impact of MS on daily life
Time Frame: 4 years
|
Multiple Sclerosis Impact Scale (MSIS-29)
|
4 years
|
|
Impact of MS on daily life
Time Frame: 5 years
|
Multiple Sclerosis Impact Scale (MSIS-29)
|
5 years
|
|
Impact of MS on daily life
Time Frame: Any relapse (maximum 5 years)
|
Multiple Sclerosis Impact Scale (MSIS-29)
|
Any relapse (maximum 5 years)
|
|
Fatigue
Time Frame: Inclusion
|
Modified Fatigue Impact Scale
|
Inclusion
|
|
Fatigue
Time Frame: 6 Months
|
Modified Fatigue Impact Scale
|
6 Months
|
|
Fatigue
Time Frame: 1 Year
|
Modified Fatigue Impact Scale
|
1 Year
|
|
Fatigue
Time Frame: 2 years
|
Modified Fatigue Impact Scale
|
2 years
|
|
Fatigue
Time Frame: 3 years
|
Modified Fatigue Impact Scale
|
3 years
|
|
Fatigue
Time Frame: 4 years
|
Modified Fatigue Impact Scale
|
4 years
|
|
Fatigue
Time Frame: 5 years
|
Modified Fatigue Impact Scale
|
5 years
|
|
Fatigue
Time Frame: Any relapse (maximum 5 years)
|
Modified Fatigue Impact Scale
|
Any relapse (maximum 5 years)
|
|
Visual acuity
Time Frame: Inclusion
|
0= low, 10= good
|
Inclusion
|
|
Visual acuity
Time Frame: 6 Months
|
0= low, 10= good
|
6 Months
|
|
Visual acuity
Time Frame: 1 Year
|
0= low, 10= good
|
1 Year
|
|
Visual acuity
Time Frame: 2 years
|
0= low, 10= good
|
2 years
|
|
Visual acuity
Time Frame: 3 years
|
0= low, 10= good
|
3 years
|
|
Visual acuity
Time Frame: 4 years
|
0= low, 10= good
|
4 years
|
|
Visual acuity
Time Frame: 5 years
|
0= low, 10= good
|
5 years
|
|
Visual acuity
Time Frame: Any relapse (maximum 5 years)
|
0= low, 10 good
|
Any relapse (maximum 5 years)
|
|
Low contrast visual acuity
Time Frame: Inclusion
|
0= low, 10 good
|
Inclusion
|
|
Low contrast visual acuity
Time Frame: 6 Months
|
0= low, 10 good
|
6 Months
|
|
Low contrast visual acuity
Time Frame: 1 Year
|
0= low, 10 good
|
1 Year
|
|
Low contrast visual acuity
Time Frame: 2 years
|
0= low, 10 good
|
2 years
|
|
Low contrast visual acuity
Time Frame: 3 years,
|
0= low, 10 good
|
3 years,
|
|
Low contrast visual acuity
Time Frame: 4 years
|
0= low, 10 good
|
4 years
|
|
Low contrast visual acuity
Time Frame: 5 years
|
0= low, 10 good
|
5 years
|
|
Low contrast visual acuity
Time Frame: Any relapse (maximum 5 years)
|
0= low, 10 good
|
Any relapse (maximum 5 years)
|
|
Relapse description
Time Frame: At relapse (maximum 5 years)
|
monofocal, plurifocal
|
At relapse (maximum 5 years)
|
|
Number of new lesions
Time Frame: At relapse (maximum 5 years)
|
Measured by MRI
|
At relapse (maximum 5 years)
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Eric Thouvenot, CHU Nimes
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- CIVI/2018/ET-01
- 2018-A03152-53 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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