Clinical trial NCT01936129: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Glaucoma, Angle-closure, Primary, Acute
Lead sponsor: Singapore Eye Research Institute
Sponsor class: OTHER
First posted: 2013-09-05
Enrollment: 196
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Visual field progression using point-wise linear regression.
timeFrame: 16 weeks
Secondary outcomes:
measure: The secondary outcome measure will be the evaluation of structural changes of the optic nerve head.
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore Eye Research Institute
Study officials:
affiliation: Singapore National Eye Centre
name: Tin Aung, FRCOphth,PhD
role: PRINCIPAL_INVESTIGATOR
References: