Linking Optic Nerve MRI and the Retinal Axonal Loss After Optic Neuritis

Optic Neuritis Clinical Trial

— IRMANO  

Official title:

Linking Optic Nerve Lesion Length at MRI and the Retinal Axonal Loss at 12 Months From a Clinical Episode of Optic Neuritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03651362
• Other study ID #: 2015_26
• Secondary ID: 2015-A01159-40
• Status: Recruiting
• Start date: February 2016
• Est. completion date: February 2019

Study information

• Verified date: August 2018
• Source: University Hospital, Lille
• Contact: Olivier Outteryck, MD, PhD
• Email: olivier.outteryck[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates the length of optic nerve lesion on 3D-DIR sequence as an imaging biomarker predictive of retinal axonal loss and visual disability, 12 months after the occurence of a first clinical episode of optic neuritis.

Description:

Neurologists and Neuro-Ophthalmologists are in need for reliable and robust imaging biomarkers enabling to predict retinal axonal loss and visual disability after clinical episode of optic neuritis (ON). Length of optic nerve lesion measured on MRI may be one of them.

The aim of our study is to measure the association between the extent of inflammatory demyelinating process on optic nerve at the acute of ON and the retinal degenerative process following optic nerve injury.

The investigators planned to include 50 patients suffering from a recent clinical episode of ON.

Extent of demyelinating inflammatory process will be assessed by the length of optic nerve double inversion recovery (DIR) hypersignal at the acute phase of ON.

The axonal degenerative process following optic nerve demyelinating injury will be assessed by retinal atrophy measured on optical coherence tomography at 12 months after ON, by visual disability measured on low vision contrast acuity scale and by microstructural quality analysis of optic nerve measured on diffusion tensor imaging sequence of the optic nerve.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patient suffering from an acute clinical episode of optic neuritis (ON) confirmed by neurophthalmological examination

• < 2 months between start of acute episode of ON and inclusion

Exclusion Criteria:

• past history of homolateral episode of ON

• retinal diseases

• diabeta mellitus

• pregnancy

Related Conditions & MeSH terms

• Neuritis
• Optic Neuritis

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHRU de Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

References & Publications (6)

Dunker S, Wiegand W. Prognostic value of magnetic resonance imaging in monosymptomatic optic neuritis. Ophthalmology. 1996 Nov;103(11):1768-73. — View Citation

Hadhoum N, Hodel J, Defoort-Dhellemmes S, Duhamel A, Drumez E, Zéphir H, Pruvo JP, Leclerc X, Vermersch P, Outteryck O. Length of optic nerve double inversion recovery hypersignal is associated with retinal axonal loss. Mult Scler. 2016 Apr;22(5):649-58. doi: 10.1177/1352458515598021. Epub 2015 Jul 30. — View Citation

Hodel J, Outteryck O, Bocher AL, Zéphir H, Lambert O, Benadjaoud MA, Chechin D, Pruvo JP, Vermersch P, Leclerc X. Comparison of 3D double inversion recovery and 2D STIR FLAIR MR sequences for the imaging of optic neuritis: pilot study. Eur Radiol. 2014 Dec;24(12):3069-75. doi: 10.1007/s00330-014-3342-3. Epub 2014 Aug 23. — View Citation

Kallenbach K, Simonsen H, Sander B, Wanscher B, Larsson H, Larsen M, Frederiksen JL. Retinal nerve fiber layer thickness is associated with lesion length in acute optic neuritis. Neurology. 2010 Jan 19;74(3):252-8. doi: 10.1212/WNL.0b013e3181ca0135. — View Citation

Miller DH, Newton MR, van der Poel JC, du Boulay EP, Halliday AM, Kendall BE, Johnson G, MacManus DG, Moseley IF, McDonald WI. Magnetic resonance imaging of the optic nerve in optic neuritis. Neurology. 1988 Feb;38(2):175-9. — View Citation

Trip SA, Schlottmann PG, Jones SJ, Altmann DR, Garway-Heath DF, Thompson AJ, Plant GT, Miller DH. Retinal nerve fiber layer axonal loss and visual dysfunction in optic neuritis. Ann Neurol. 2005 Sep;58(3):383-91. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of retinal axonal loss around papilla after a clinical episode of optic neuritis	peripapillary RNFL thickness decrease	12 months
Secondary	Severity of retinal axonal loss within macula after a clinical episode of optic neuritis	macular volume decrease	12 months
Secondary	Severity of visual disability after a clinical episode of optic neuritis	monocular low contrast (2.5%) vision	12 months
Secondary	Severity of microstructural architecture of optic nerve after a clinical episode of optic neuritis	fractional anisotropy	12 months
Secondary	Progression of optic nerve lesion length	lesion length in mm measured on 3D-double inversion recovery sequence	12 months