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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

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.

Condition or disease Intervention/treatment Phase
Glaucoma, Angle-closure, Primary, Acute Drug: Copaxone Drug: Placebo (buffered normal saline w/v) Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Investigating the Neuroprotective Effect of Cop-1 in Acute Primary Angle Closure
Study Start Date : September 2010
Estimated Primary Completion Date : October 2013

Resource links provided by the National Library of Medicine


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.
Drug: Copaxone
Other Names:
  • Cop 1
  • glatiramer acetate

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.
Drug: Placebo (buffered normal saline w/v)



Primary Outcome Measures :
  1. Visual field progression using point-wise linear regression. [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. The secondary outcome measure will be the evaluation of structural changes of the optic nerve head. [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936129


Contacts
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Contact: Tin Aung, FRCOphth,PhD 6563224500 aung.tin@snec.com.sg
Contact: Monisha E Nongpiur, MD 6563224500 monisha.esther.nongpiur@seri.com.sg

Locations
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Singapore
Singapore Eye Research Institute Recruiting
Singapore, Singapore, 168751
Contact: Tin Aung, FRCOphth,PhD    6563224500    aung.tin@snec.com.sg   
Sponsors and Collaborators
Singapore Eye Research Institute
Investigators
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Principal Investigator: Tin Aung, FRCOphth,PhD Singapore National Eye Centre

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Responsible Party: Prof Aung Tin, Professor, Singapore Eye Research Institute
ClinicalTrials.gov Identifier: NCT01936129     History of Changes
Other Study ID Numbers: R624/45/2008
First Posted: September 5, 2013    Key Record Dates
Last Update Posted: September 6, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
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Glatiramer Acetate
Glaucoma, Angle-Closure
Glaucoma
Ocular Hypertension
Eye Diseases
(T,G)-A-L
Neuroprotective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Protective Agents