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TLR-9 Antagonism in Steroid Resistant Optic Neuritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01424735
First Posted: August 29, 2011
Last Update Posted: August 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aditya Sudhalkar, Sudhalkar Eye Hospital
August 25, 2011
August 29, 2011
August 29, 2011
July 2006
January 2010   (Final data collection date for primary outcome measure)
Improvement in all aspects of visual function [ Time Frame: upto 6 months ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
TLR-9 Antagonism in Steroid Resistant Optic Neuritis
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Optic Neuritis
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 Name: IMMUVAC
Experimental: Mw.
Administration of immunomodulator Mw.
Intervention: Drug: Mycobacterium w.(Mw)-freeze dried extract 0.5ml
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
May 2010
January 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Unilateral Steroid Resistant Optic Neuritis

Exclusion Criteria:

  • bilateral optic neuritis
  • Associated Systemic disease
  • Prior treatment received
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01424735
21234EH
Yes
Not Provided
Not Provided
Aditya Sudhalkar, Sudhalkar Eye Hospital
Sudhalkar Eye Hospital
Not Provided
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
Sudhalkar Eye Hospital
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP