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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
  Purpose
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.

Condition Intervention
Optic Neuritis Drug: Mycobacterium w.(Mw)-freeze dried extract 0.5ml

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcomes of TLR-9 Antagonism in Steroid Resistant Optic Neuritis; A Pilot Study

Resource links provided by NLM:


Further study details as provided by Aditya Sudhalkar, Sudhalkar Eye Hospital:

Primary Outcome Measures:
  • Improvement in all aspects of visual function [ Time Frame: upto 6 months ]

Enrollment: 8
Study Start Date: July 2006
Study Completion Date: May 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: IMMUVAC

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Unilateral Steroid Resistant Optic Neuritis

Exclusion Criteria:

  • bilateral optic neuritis
  • Associated Systemic disease
  • Prior treatment received
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424735


Locations
India
Sudhalkar Eye Hospital
Baroda, Gujarat, India, 390001
Sponsors and Collaborators
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
  More Information

Responsible Party: Aditya Sudhalkar, Dr. Aditya Sudhalkar, Sudhalkar Eye Hospital
ClinicalTrials.gov Identifier: NCT01424735     History of Changes
Other Study ID Numbers: 21234EH
First Submitted: August 25, 2011
First Posted: August 29, 2011
Last Update Posted: August 29, 2011
Last Verified: August 2011

Keywords provided by Aditya Sudhalkar, Sudhalkar Eye Hospital:
Best corrected Visual Acuity
Pupillary Reaction
Colour vision
Disc edema

Additional relevant MeSH terms:
Neuritis
Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases