Investigating the Neuroprotective Effect of Cop-1 (Copaxone) in Acute Primary Angle Closure
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|ClinicalTrials.gov Identifier: NCT01936129|
Recruitment Status : Unknown
Verified September 2013 by Prof Aung Tin, Singapore Eye Research Institute.
Recruitment status was: Recruiting
First Posted : September 5, 2013
Last Update Posted : September 6, 2013
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma, Angle-closure, Primary, Acute||Drug: Copaxone Drug: Placebo (buffered normal saline w/v)||Phase 3|
Aim To assess the neuroprotective effect of Cop-1 (Copaxone) in reducing functional and structural damage after acute primary angle closure (APAC)
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||196 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Investigating the Neuroprotective Effect of Cop-1 in Acute Primary Angle Closure|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||October 2013|
Active Comparator: Copaxone
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 Comparator: Placebo
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)
- Visual field progression using point-wise linear regression. [ Time Frame: 16 weeks ]
- The secondary outcome measure will be the evaluation of structural changes of the optic nerve head. [ Time Frame: 16 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936129
|Contact: Tin Aung, FRCOphth,PhDemail@example.com|
|Contact: Monisha E Nongpiur, MDfirstname.lastname@example.org|
|Singapore Eye Research Institute||Recruiting|
|Singapore, Singapore, 168751|
|Contact: Tin Aung, FRCOphth,PhD 6563224500 email@example.com|
|Principal Investigator:||Tin Aung, FRCOphth,PhD||Singapore National Eye Centre|