TLR-9 Antagonism in Steroid Resistant Optic Neuritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aditya Sudhalkar, Sudhalkar Eye Hospital
ClinicalTrials.gov Identifier:
NCT01424735
First received: August 25, 2011
Last updated: August 26, 2011
Last verified: August 2011

August 25, 2011
August 26, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01424735 on ClinicalTrials.gov Archive Site
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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.

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Interventional
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Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
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*   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
Both
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No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01424735
21234EH
Yes
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