TLR-9 Antagonism in Steroid Resistant Optic Neuritis

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.

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Key information

Conditions

Optic Neuritis Cranial Nerve Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Optic Nerve Diseases Pathological Conditions, Signs and Symptoms Pupil Disorders Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sudhalkar Eye Hospital

Vadodara, Gujarat, 390001, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Unilateral Steroid Resistant Optic Neuritis

Exclusion criteria

bilateral optic neuritis
Associated Systemic disease
Prior treatment received

Treatment and study plan

Mycobacterium w.(Mw)-freeze dried extract 0.5ml

Drug

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 names: IMMUVAC

Primary outcomes

Improvement in all aspects of visual function

Time frame: upto 6 months

Sponsors and collaborators

Lead sponsor

Sudhalkar Eye Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2010
Study completion: 2010
First posted: Aug 29, 2011
Registry last updated: Aug 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed