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TLR-9 Antagonism in Steroid Resistant Optic Neuritis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01424735
Enrollment
8
Registered
2011-08-29
Start date
2006-07-31
Completion date
2010-05-31
Last updated
2011-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optic Neuritis

Keywords

Best corrected Visual Acuity, Pupillary Reaction, Colour vision, Disc edema

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.

Interventions

DRUGMycobacterium 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

Sponsors

Sudhalkar Eye Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Unilateral Steroid Resistant Optic Neuritis

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Improvement in all aspects of visual functionupto 6 months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026