A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Glatiramer Acetate (GA) on the Retinal Nerve Fiber Layer (RNFL) and Visual Function in Patients With a First Episode of Acute Optic Neuritis (AON). (Octagon)
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|ClinicalTrials.gov Identifier: NCT00856635|
Recruitment Status : Completed
First Posted : March 6, 2009
Results First Posted : September 23, 2013
Last Update Posted : February 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Optic Neuritis||Drug: Glatiramer Acetate Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Glatiramer Acetate (GA) on the Retinal Nerve Fiber Layer (RNFL) and Visual Function in Patients With a First Episode of Acute Optic Neuritis (AON)|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||February 2011|
Experimental: Glatiramer acetate
Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
Drug: Glatiramer Acetate
20 mg injected daily subcutaneously
Other Name: Copaxone
Placebo Comparator: Placebo
Participants received placebo subcutaneous injection once a day for up to 6 months.
injected daily subcutaneously
- Retinal Nerve Fiber Layer Thickness at Baseline and Month 6 [ Time Frame: Baseline and Month 6 ]Axonal loss in the optic nerve (due to optic neuritis) was assessed by measuring retinal nerve fiber thickness of the affected eye using optical coherence tomography (OCT) at Baseline and Month 6.
- To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters. [ Time Frame: 6 months ]
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): NCT00856635
|Principal Investigator:||Mark J. Kupersmith, MD||Roosevelt Hospital|
|Principal Investigator:||Peter Calabresi, MD||John Hopkins School of Medicine|