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

NCT01936129 | Unknown Phase 3 DMC

• 1 other identifier: R624/45/2008
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma, Angle-closure, Primary, Acute

Outcome Measures

Primary Outcomes (1)

• Visual field progression using point-wise linear regression.

  16 weeks

Secondary Outcomes (1)

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

  16 weeks

Study Arms (2)

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.

Drug: Copaxone

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.

Drug: Placebo (buffered normal saline w/v)

Interventions

Copaxone DRUG

Also known as: Cop 1, glatiramer acetate

Copaxone

Placebo (buffered normal saline w/v) DRUG

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singapore Eye Research Institute: lead

Study Sites (1)

Singapore Eye Research Institute

Singapore, Singapore, 168751, Singapore

RECRUITING

MeSH Terms

Conditions

Glaucoma

Interventions

Glatiramer Acetate; Coat Protein Complex I

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Vesicular Transport Proteins; Membrane Proteins; Proteins

Study Officials

• Tin Aung, FRCOphth,PhD

  Singapore National Eye Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tin Aung, FRCOphth,PhD

CONTACT

6563224500; aung.tin@snec.com.sg

Monisha E Nongpiur, MD

CONTACT

6563224500; monisha.esther.nongpiur@seri.com.sg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 5, 2013
• Study Start: September 1, 2010
• Primary Completion: October 1, 2013
• Last Updated: September 6, 2013

Record last verified: 2013-09

Locations

SG (1)