NCT01424735

Brief Summary

Although idiopathic steroid resistant optic neuritis is very uncommon, there is no established treatment protocol for such patients. Toll like receptors (TLRs) especially TLR-9 has been shown to play a role in the pathogenesis of optic neuritis. This small case series aims to determine whether immunomodulators directed specifically at TLR-9(i.e. TLR-9 antagonism)play any role in improving the visual function in such patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2011

Completed
Last Updated

August 29, 2011

Status Verified

August 1, 2011

Enrollment Period

3.5 years

First QC Date

August 25, 2011

Last Update Submit

August 26, 2011

Conditions

Optic Neuritis

Keywords

Best corrected Visual AcuityPupillary ReactionColour visionDisc edema

Outcome Measures

Primary Outcomes (1)

  • Improvement in all aspects of visual function

    upto 6 months

Study Arms (1)

Mw.

EXPERIMENTAL

Administration of immunomodulator Mw.

Drug: Mycobacterium w.(Mw)-freeze dried extract 0.5ml

Interventions

Mycobacterium w.(Mw)-freeze dried extract 0.5mlDRUG

0.5 ml of Mw in 500ml 0.9% normal saline administered over two hours as an infusion. 2ml(4mg/ml) of dexamethasone administered two hours prior to Mw administration

Also known as: IMMUVAC
Mw.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral Steroid Resistant Optic Neuritis

You may not qualify if:

  • bilateral optic neuritis
  • Associated Systemic disease
  • Prior treatment received

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sudhalkar Eye Hospital

Vadodara, Gujarat, 390001, India

Location

MeSH Terms

Conditions

Optic NeuritisPupil Disorders

Interventions

Immuvac

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bakulesh M Khamar, M.S. Ophthalmology

    Thakore Eye Hospital, Ahmedabad

    PRINCIPAL INVESTIGATOR

  • Mayuri B Khamar, M.S.Ophthalmology

    M & J Institute Of Ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Aditya Sudhalkar

Study Record Dates

First Submitted

August 25, 2011

First Posted

August 29, 2011

Study Start

July 1, 2006

Primary Completion

January 1, 2010

Study Completion

May 1, 2010

Last Updated

August 29, 2011

Record last verified: 2011-08

Locations

IN(1)