TLR-9 Antagonism in Steroid Resistant Optic Neuritis

NCT ID: NCT01424735

Last Updated: 2011-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-05-31

Brief Summary

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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

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Conditions

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Optic Neuritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mw.

Administration of immunomodulator Mw.

Group Type EXPERIMENTAL

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

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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IMMUVAC

Eligibility Criteria

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Inclusion Criteria

Unilateral Steroid Resistant Optic Neuritis

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sudhalkar Eye Hospital

OTHER

Sponsor Role lead

Responsible Party

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Aditya Sudhalkar

Dr. Aditya Sudhalkar

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bakulesh M Khamar, M.S. Ophthalmology

Role: PRINCIPAL_INVESTIGATOR

Thakore Eye Hospital, Ahmedabad

Mayuri B Khamar, M.S.Ophthalmology

Role: PRINCIPAL_INVESTIGATOR

M & J Institute Of Ophthalmology

Locations

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Sudhalkar Eye Hospital

Vadodara, Gujarat, India

Site Status

Countries

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India

Other Identifiers

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21234EH

Identifier Type: -

Identifier Source: org_study_id

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