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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Sudhalkar Eye Hospital:

Primary Outcome Measures:
  • Improvement in all aspects of visual function [ Time Frame: upto 6 months ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Aditya Sudhalkar, Dr. Aditya Sudhalkar, Sudhalkar Eye Hospital
ClinicalTrials.gov Identifier: NCT01424735     History of Changes
Other Study ID Numbers: 21234EH
Study First Received: August 25, 2011
Last Updated: August 26, 2011
Health Authority: India: Drugs Controller General of India

Keywords provided by 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

ClinicalTrials.gov processed this record on September 16, 2014