Condition category
Eye Diseases
Date applied
06/10/2013
Date assigned
06/08/2014
Last edited
06/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Plasma exchange (PE) is a procedure where the plasma of the blood is replaced by another component called plasma substitute. It has been used as an escalation treatment and after failure of high doses of steroids in the treatment of optic neuritis (inflammation of the optic nerve). However, until now only one study has evaluated PE for the treatment of MS relapses. The current experience in treating optic neuritis that does not respond to steroids with PE is limited. This study will be the first rigorous clinical study in severe optic neuritis that does not respond to steroids, and will provide evidence regarding the effectiveness of PE in optic neuritis.

Who can participate?
Adult patients with optic neuritis that did not respond to steroid treatment and an overall duration of symptoms of less than 4 weeks.

What does the study involve?
Patients will be randomly allocated to two different treatment options: five cycles of plasma exchange or methylprednisolone (a very high dosage of steroid) for five consecutive days.

What are the possible benefits and risks of participating?
Both the treatment options in this study are established therapies so we do not expect to observe unpredictable risks or side effects. If patients in the steroid treatment arm do not respond well, we offer the rescue treatment with plasma exchange 8 weeks after the steroid treatment.

Where is the study run from?
The study will be conducted in five centres in Germany (Hamburg, Heidelberg, Hannover, Berlin and Düsseldorf). The lead centre will be Hamburg.

When is the study starting and how long is it expected to run for?
The study started in October 2013 and will last for about 2 years.

Who is funding the study?
The Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung) (BMBF) (Germany).

Who is the main contact?
Prof Christoph Heesen
heesen@uke.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Christoph Heesen

ORCID ID

Contact details

Institute of Neuroimmunology and Clinical MS Research
and Department of Neurology
UKE
Martinistrasse 52
Hamburg
20246
Germany
heesen@uke.de

Additional identifiers

EudraCT number

2012-004807-10

ClinicalTrials.gov number

Protocol/serial number

inims-004

Study information

Scientific title

Relapse ESCalation treatment trial in Optic Neuritis (RESCON): a multi-centre randomised controlled trial to study the effectiveness of plasma exchange (PE) as an escalation treatment strategy in steroid-unresponsive optic neuritis

Acronym

RESCON

Study hypothesis

Primary objectives:
1. To gain further evidence for the efficacy of plasma exchange in steroid-unresponsive optic neuritis
2. To study new outcome tools for neuronal regeneration in the ON model via optical coherence tomography (OCT)

Secondary objectives:
1. To study MRI parameters in patients with steroid-unresponsive optic neuritis treated with plasma exchange (contrast-enhancement, T2-signal, edema and atrophy will be assessed as well as diffusion tensor imaging (DTI) at baseline, week 16 and 52)
2. To further study biomarkers for ON heterogeneity and neurodegeneration

Ethics approval

Ethics Committee of Hamburg, 17/07/2013

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Steroid-unresponsive optic neuritis

Intervention

RCT in patients who suffer from severe optic neuritis without satisfying improvement after treatment with steroids.

Treatment arm 1: plasma exchange (PE)
PE will be performed every second day; altogether five exchanges are planned. Each procedure will last about 2-3 hours. After placing a central venous catheter in a jugular or subclavian vein the 1.5-fold plasma volume will be exchanged with the same volume of human albumin 5% or a combination of albumin and hemodilution by continuous-flow centrifugation using a cell separation device.

Treatment arm 2: ultrahigh-dose steroid treatment
Each day 2 g of methylprednisolone will be administered intravenously on five consecutive days.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Mean retina nerve fiber layer thickness in OCT at week 16 after treatment in comparison between groups

Secondary outcome measures

1. Treatment failure at week 2
2. Visual acuity measured at inclusion, week 2, 4, 8, 16, 52 after treatment
3. Visual evoked potential latency measured at inclusion, week 2, 4, 8, 16, 52 after treatment
4. MRI parameters at week 1, 2, 4, 16, 52

Overall trial start date

10/10/2013

Overall trial end date

10/10/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Optic neuritis with visual acuity < 0.7 at least 7 days after steroid treatment (3-5 x 1 g)
2. Duration of symptoms from onset < 4 weeks
3. Male and female, age: 18-60 years
4. Expanded Disability Status Scale (EDSS): 1.0 – 6.5
5. Clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RR-MS) or secondary progressive multiple sclerosis (SP-MS)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Absence of evidence of inflammatory activity which is defined as a lack of inflammatory CSF signs (pleocytosis and/or OCBs) or a present MRI without at least two MS-typical lesions
2. Bilateral optic neuritis
3. Positive testing for aquaporin-4 antibodies
4. Current treatment with natalizumab
5. Patients with neuromyelitis optica
6. Pregnancy
7. Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the patient returning for follow-up visits on schedule.
Patients with cognitive impairments who are unable to provide written, informed consent prior to any testing under this protocol.

Recruitment start date

10/10/2013

Recruitment end date

10/10/2015

Locations

Countries of recruitment

Germany

Trial participating centre

Institute of Neuroimmunology and Clinical MS Research
Hamburg
20246
Germany

Sponsor information

Organisation

University Medical Center Hamburg-Eppendorf (Universitätsklinikum Hamburg-Eppendorf) (Germany)

Sponsor details

c/o Prof. Dr. Dr. Uwe Koch-Gromus
Martinistrasse 52
Hamburg
D-20246
Germany

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

The Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung) (BMBF) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes