TLR-9 Antagonism in Steroid Resistant Optic Neuritis

Not Applicable

Completed

• Conditions: Optic Neuritis
• Interventions: Drug: Mycobacterium w.(Mw)-freeze dried extract 0.5ml

• Registration Number: NCT01424735
• Lead Sponsor: Sudhalkar Eye Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2010-01
• Study Completion: 2010-05
• Status Verified: 2011-08
• Study First Submitted: 2011-08-25
• Study First Submitted QC: 2011-08-26
• Last Update Submitted: 2011-08-26
• Study First Posted: 2011-08-29
• Last Update Posted: 2011-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Unilateral Steroid Resistant Optic Neuritis

Exclusion Criteria

• bilateral optic neuritis
• Associated Systemic disease
• Prior treatment received

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mw.	Mycobacterium w.(Mw)-freeze dried extract 0.5ml	Administration of immunomodulator Mw.

Primary Outcome Measures

Name	Time	Method
Improvement in all aspects of visual function	upto 6 months

Trial Locations

Locations (1)

Sudhalkar Eye Hospital; 🇮🇳 Baroda, Gujarat, India