Optic NeuritisNCT01424735
TLR-9 Antagonism in Steroid Resistant Optic Neuritis
A study testing Mycobacterium w.(Mw)-freeze dried extract 0.5ml in people with Optic Neuritis, run by Sudhalkar Eye Hospital at 1 site in India.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Optic Neuritis
- What is being tested?
- Mycobacterium w.(Mw)-freeze dried extract 0.5ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2006to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Unilateral Steroid Resistant Optic Neuritis
Who cannot join
- bilateral optic neuritis
- Associated Systemic disease
- Prior treatment received
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of TLR-9 Antagonism in Steroid Resistant Optic Neuritis; A Pilot Study
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.
- Conditions
- Optic Neuritis
- Being tested
- Mycobacterium w.(Mw)-freeze dried extract 0.5ml
- Keywords
- Best corrected Visual Acuity, Pupillary Reaction, Colour vision, Disc edema
- Medical subject headings
- Optic Neuritis, Pupil Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycobacterium w.(Mw)-freeze dried extract 0.5mlDrug
Also called IMMUVAC
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
| Study group | Role | What they receive |
|---|---|---|
| Mw. | Experimental | Administration of immunomodulator Mw. Receives: Drug: Mycobacterium w.(Mw)-freeze dried extract 0.5ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in all aspects of visual function
Measured: upto 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startJul 2006
- Primary completionJan 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NeuritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sudhalkar Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aditya Sudhalkar, Sudhalkar Eye Hospital
- Investigators
- Bakulesh M Khamar, M.S. Ophthalmology, Principal investigator, Thakore Eye Hospital, AhmedabadMayuri B Khamar, M.S.Ophthalmology, Principal investigator, M & J Institute Of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424735
- Sponsor's protocol ID
- 21234EH
- Status last verified
- Aug 2011
- First submitted
- 25 Aug 2011
- Last updated
- 29 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of TLR-9 Antagonism in Steroid Resistant Optic Neuritis; A Pilot Study
- ClinicalTrials.gov ID
- NCT01424735
- Acronym / sponsor ID
- 21234EH
- Conditions
- Optic Neuritis
- Keywords
- Best corrected Visual Acuity, Pupillary Reaction, Colour vision, Disc edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sudhalkar Eye HospitalUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 29 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mw. | Experimental | Drug: Mycobacterium w.(Mw)-freeze dried extract 0.5mlAdministration of immunomodulator Mw. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Unilateral Steroid Resistant Optic Neuritis
Key exclusion criteria (3 listed)
- bilateral optic neuritis
- Associated Systemic disease
- Prior treatment received
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mycobacterium w.(Mw)-freeze dried extract 0.5mlAlso: IMMUVAC0.5 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 | Drug | Mw. |
Primary outcome
Improvement in all aspects of visual function
Time frame: upto 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bakulesh M Khamar, M.S. Ophthalmology principal investigator
Thakore Eye Hospital, Ahmedabad
Mayuri B Khamar, M.S.Ophthalmology principal investigator
M & J Institute Of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mycobacterium w.(Mw)-freeze dried extract 0.5ml in people with Optic Neuritis, run by Sudhalkar Eye Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in all aspects of visual function (time frame: upto 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2011.