TLR-9 Antagonism in Steroid Resistant Optic Neuritis

August 26, 2011 updated by: Aditya Sudhalkar, Sudhalkar Eye Hospital

Outcomes of TLR-9 Antagonism in Steroid Resistant Optic Neuritis; A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujarat
      • Baroda, Gujarat, India, 390001
        • Sudhalkar Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Unilateral Steroid Resistant Optic Neuritis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mw.
Administration of immunomodulator Mw.
Drug: Mycobacterium w.(Mw)-freeze dried extract 0.5ml
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
Other Names:
  • IMMUVAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in all aspects of visual function
Time Frame: upto 6 months
upto 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sudhalkar Eye Hospital

Investigators

  • Principal Investigator: Bakulesh M Khamar, M.S. Ophthalmology, Thakore Eye Hospital, Ahmedabad
  • Principal Investigator: Mayuri B Khamar, M.S.Ophthalmology, M & J Institute Of Ophthalmology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

August 25, 2011

First Submitted That Met QC Criteria

August 26, 2011

First Posted (Estimate)

August 29, 2011

Study Record Updates

Last Update Posted (Estimate)

August 29, 2011

Last Update Submitted That Met QC Criteria

August 26, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21234EH

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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