Back to resultsTLR-9 Antagonism in Steroid Resistant Optic Neuritis
Primary Purpose
Optic Neuritis
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Mycobacterium w.(Mw)-freeze dried extract 0.5ml
Sponsored by
About this trial
This is an interventional treatment trial for Optic Neuritis focused on measuring Best corrected Visual Acuity, Pupillary Reaction, Colour vision, Disc edema
Eligibility Criteria
Inclusion Criteria:
Unilateral Steroid Resistant Optic Neuritis
Exclusion Criteria:
- bilateral optic neuritis
- Associated Systemic disease
- Prior treatment received
Sites / Locations
- Sudhalkar Eye Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mw.
Arm Description
Administration of immunomodulator Mw.
Outcomes
Primary Outcome Measures
Improvement in all aspects of visual function
Secondary Outcome Measures
Full Information
NCT ID
NCT01424735
First Posted
August 25, 2011
Last Updated
August 26, 2011
Sponsor
Sudhalkar Eye Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01424735
Brief Title
TLR-9 Antagonism in Steroid Resistant Optic Neuritis
Official Title
Outcomes of TLR-9 Antagonism in Steroid Resistant Optic Neuritis; A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sudhalkar Eye Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Neuritis
Keywords
Best corrected Visual Acuity, Pupillary Reaction, Colour vision, Disc edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mw.
Arm Type
Experimental
Arm Description
Administration of immunomodulator Mw.
Intervention Type
Drug
Intervention Name(s)
Mycobacterium w.(Mw)-freeze dried extract 0.5ml
Other Intervention Name(s)
IMMUVAC
Intervention Description
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
Primary Outcome Measure Information:
Title
Improvement in all aspects of visual function
Time Frame
upto 6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral Steroid Resistant Optic Neuritis
Exclusion Criteria:
bilateral optic neuritis
Associated Systemic disease
Prior treatment received
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bakulesh M Khamar, M.S. Ophthalmology
Organizational Affiliation
Thakore Eye Hospital, Ahmedabad
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mayuri B Khamar, M.S.Ophthalmology
Organizational Affiliation
M & J Institute Of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sudhalkar Eye Hospital
City
Baroda
State/Province
Gujarat
ZIP/Postal Code
390001
Country
India
12. IPD Sharing Statement
Learn more about this trial
TLR-9 Antagonism in Steroid Resistant Optic Neuritis
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