- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01936129
Investigating the Neuroprotective Effect of Cop-1 (Copaxone) in Acute Primary Angle Closure
Investigating the Neuroprotective Effect of Cop-1 in Acute Primary Angle Closure
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aim To assess the neuroprotective effect of Cop-1 (Copaxone) in reducing functional and structural damage after acute primary angle closure (APAC)
Outcome measures:
The primary outcome measures will be the point-wise linear regression in the visual fields.
The secondary outcome measure will be the evaluation of structural changes, namely, RNFL thickness and Optic disc changes as measured by stratus OCT and HRT respectively.
Study population
The study population (n=196; 1:1 randomisation) will be patients with APAC attending the Singapore National Eye Centre who fulfil the inclusion criteria and are willing to take part in the study.
Study design:
The study design is a randomized, placebo controlled, double blinded trial where patients with APAC will be randomized to receive either Cop-1 (Copaxone) or placebo in addition to the standard medical therapy.
An interim analysis will be conducted after 40 patients complete the trial. Routine examination will be done at all visits.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Tin Aung, FRCOphth,PhD
- Phone Number: 6563224500
- Email: aung.tin@snec.com.sg
Study Contact Backup
- Name: Monisha E Nongpiur, MD
- Phone Number: 6563224500
- Email: monisha.esther.nongpiur@seri.com.sg
Study Locations
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Singapore, Singapore, 168751
- Recruiting
- Singapore Eye Research Institute
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Contact:
- Tin Aung, FRCOphth,PhD
- Phone Number: 6563224500
- Email: aung.tin@snec.com.sg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• patients with APAC who present to the centre not later than 7 days from the initiation of the attack.
- the presence of at least two of the following symptoms: ocular or periocular pain, nausea or vomiting or both, and an antecedent history of blurring of vision with haloes;
- a presenting intraocular pressure of at least 28 mm Hg on Goldmann applanation tonometry;
- the presence of at least three of the following signs: conjunctival injection, corneal epithelial oedema, middilated unreactive pupil, and shallow anterior chamber;
- the presence of an occludable angle in the affected eye on gonioscopy;
- Age more than 21 years.
- Informed consent
Exclusion Criteria:
• evidence of a prior acute angle closure attack (the presence of iris whorling, focal iris atrophy, or glaucomflecken with a history of an acute red eye and decreased vision). This will not include senile iris and sphincter atrophy);
- Pre-existing chronic angle closure glaucoma in the eye with APAC
- secondary causes of angle closure like subluxed lens, uveitis, trauma and neovascular glaucoma;
- cataract that is deemed significant enough to require surgery during the course of the trial or that makes field testing or optic disc imaging not technically possible- visual acuity less than 6/36 due to any type of cataract;
- corneal abnormalities, media opacities, or retinal abnormalities that would affect scanning laser polarimetry;
- previous intraocular surgery;
- currently pregnant or nursing women, or women considering pregnancy;
- Severe health problems precluding follow-up such as end-stage heart disease, kidney disease, respiratory disease, or cancer and life expectancy less than one year.
- History of allergy to mannitol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Copaxone
COPAXONE (glatiramer acetate) will be administered as a subcutaneous dose (20mg) once, one injection no later than 7 days from the initiation of the attack, and 1 more injection administered one week after the first injection.
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Other Names:
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Placebo Comparator: Placebo
Placebo (buffered normal saline w/v)will be administered as a subcutaneous dose, one injection no later than 7 days from the initiation of the attack, and 1 more injection administered one week after the first injection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual field progression using point-wise linear regression.
Time Frame: 16 weeks
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16 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The secondary outcome measure will be the evaluation of structural changes of the optic nerve head.
Time Frame: 16 weeks
|
16 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tin Aung, FRCOphth,PhD, Singapore National Eye Centre
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R624/45/2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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