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TLR-9 Antagonism in Steroid Resistant Optic Neuritis

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ClinicalTrials.gov Identifier: NCT01424735
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : August 29, 2011
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
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
Study Start Date : July 2006
Primary Completion Date : January 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions

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 Name: IMMUVAC

Outcome Measures

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

Eligibility Criteria

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

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

Sudhalkar Eye Hospital
Baroda, Gujarat, India, 390001
Sponsors and Collaborators
Sudhalkar Eye Hospital
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 Posted: August 29, 2011    Key Record Dates
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:
Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases