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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)

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

NCT ID

NCT01936129

First Posted

August 28, 2013

Last Updated

September 4, 2013

Sponsor

Singapore Eye Research Institute

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

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

aung.tin@snec.com.sg

First Name & Middle Initial & Last Name or Official Title & Degree

Monisha E Nongpiur, MD

Phone

6563224500

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

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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