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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Copaxone | Active Comparator | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copaxone | Drug |
|
| |
| Placebo (buffered normal saline w/v) |
| Measure | Description | Time Frame |
|---|---|---|
| Visual field progression using point-wise linear regression. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary outcome measure will be the evaluation of structural changes of the optic nerve head. | 16 weeks |
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Inclusion Criteria:
• patients with APAC who present to the centre not later than 7 days from the initiation of the attack.
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);
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tin Aung, FRCOphth,PhD | Contact | 6563224500 | aung.tin@snec.com.sg | |
| Monisha E Nongpiur, MD | Contact | 6563224500 | monisha.esther.nongpiur@seri.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Tin Aung, FRCOphth,PhD | Singapore National Eye Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore Eye Research Institute | Recruiting | Singapore | Singapore | 168751 | Singapore |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068717 | Glatiramer Acetate |
| D020755 | Coat Protein Complex I |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D033921 | Vesicular Transport Proteins |
| D008565 | Membrane Proteins |
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| Drug |
|
| D011506 | Proteins |