TLR-9 Antagonism in Steroid Resistant Optic Neuritis

Optic Neuritis Clinical Trial

Official title:

Outcomes of TLR-9 Antagonism in Steroid Resistant Optic Neuritis; A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01424735
• Other study ID #: 21234EH
• Status: Completed
• Phase: N/A
• First received: August 25, 2011
• Last updated: August 26, 2011
• Start date: July 2006
• Est. completion date: May 2010

Study information

• Verified date: August 2011
• Source: Sudhalkar Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Unilateral Steroid Resistant Optic Neuritis

Exclusion Criteria:

• bilateral optic neuritis

• Associated Systemic disease

• Prior treatment received

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuritis
• Optic Neuritis

Intervention

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

Locations

Country	Name	City	State
India	Sudhalkar Eye Hospital	Baroda	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Sudhalkar Eye Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in all aspects of visual function		upto 6 months	Yes