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

Primary Purpose

Glaucoma, Angle-closure, Primary, Acute

Status
Unknown status
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
Copaxone
Placebo (buffered normal saline w/v)
Sponsored by
Singapore Eye Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Glaucoma, Angle-closure, Primary, Acute

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Singapore Eye Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Copaxone

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Visual field progression using point-wise linear regression.

Secondary Outcome Measures

The secondary outcome measure will be the evaluation of structural changes of the optic nerve head.

Full Information

First Posted
August 28, 2013
Last Updated
September 4, 2013
Sponsor
Singapore Eye Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01936129
Brief Title
Investigating the Neuroprotective Effect of Cop-1 (Copaxone) in Acute Primary Angle Closure
Official Title
Investigating the Neuroprotective Effect of Cop-1 in Acute Primary Angle Closure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Singapore Eye Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Angle-closure, Primary, Acute

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Copaxone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Copaxone
Other Intervention Name(s)
Cop 1, glatiramer acetate
Intervention Type
Drug
Intervention Name(s)
Placebo (buffered normal saline w/v)
Primary Outcome Measure Information:
Title
Visual field progression using point-wise linear regression.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
The secondary outcome measure will be the evaluation of structural changes of the optic nerve head.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tin Aung, FRCOphth,PhD
Phone
6563224500
Email
aung.tin@snec.com.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Monisha E Nongpiur, MD
Phone
6563224500
Email
monisha.esther.nongpiur@seri.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tin Aung, FRCOphth,PhD
Organizational Affiliation
Singapore National Eye Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore Eye Research Institute
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tin Aung, FRCOphth,PhD
Phone
6563224500
Email
aung.tin@snec.com.sg

12. IPD Sharing Statement

Learn more about this trial

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

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