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Investigating the Neuroprotective Effect of Cop-1 (Copaxone) in Acute Primary Angle Closure

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ClinicalTrials.gov Identifier: NCT01936129
Recruitment Status : Unknown
Verified September 2013 by Prof Aung Tin, Singapore Eye Research Institute.
Recruitment status was:  Recruiting
First Posted : September 5, 2013
Last Update Posted : September 6, 2013
Sponsor:
Information provided by (Responsible Party):
Prof Aung Tin, Singapore Eye Research Institute

Tracking Information
First Submitted Date  ICMJE August 28, 2013
First Posted Date  ICMJE September 5, 2013
Last Update Posted Date September 6, 2013
Study Start Date  ICMJE September 2010
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2013)
Visual field progression using point-wise linear regression. [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01936129 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2013)
The secondary outcome measure will be the evaluation of structural changes of the optic nerve head. [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigating the Neuroprotective Effect of Cop-1 (Copaxone) in Acute Primary Angle Closure
Official Title  ICMJE Investigating the Neuroprotective Effect of Cop-1 in Acute Primary Angle Closure
Brief Summary This is a randomised controlled trial to assess the neuroprotective effect of Cop-1 (Copaxone) in patients with acute primary angle closure (APAC). The standardized management of APAC will include medical therapy to reduce intraocular pressure (IOP), followed by laser peripheral iridotomy. Cop-1 will be administered in addition to standard therapy as a subcutaneous dose once within 24 hours of presentation, and then one week later (total 2 injections). The control group will have placebo in addition to standard regimen. Subjects in the study will have visual field test performed with the Humphrey Visual Field Analyzer II, retinal nerve fibre layer (RNFL) thickness measured with the Stratus optical coherence tomography (OCT) and Optic nerve head evaluated with the Heidelberg retinal tomography (HRT). At least 2 baseline visual field tests will also be performed in the first week. Subsequent visits will be at week 4, 8, 12 and 16. The outcome criteria will be difference in visual field, RNFL thickness, and optic nerve head structural changes.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Glaucoma, Angle-closure, Primary, Acute
Intervention  ICMJE
  • Drug: Copaxone
    Other Names:
    • Cop 1
    • glatiramer acetate
  • Drug: Placebo (buffered normal saline w/v)
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Copaxone
  • 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.
    Intervention: Drug: Placebo (buffered normal saline w/v)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 1, 2013)
196
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01936129
Other Study ID Numbers  ICMJE R624/45/2008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof Aung Tin, Singapore Eye Research Institute
Study Sponsor  ICMJE Singapore Eye Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tin Aung, FRCOphth,PhD Singapore National Eye Centre
PRS Account Singapore Eye Research Institute
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP