Back to resultsA 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)
Primary Purpose
Optic Neuritis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Glatiramer Acetate
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Optic Neuritis
Eligibility Criteria
Inclusion Criteria:
- Age: 18 - 45 years
- Isolated, unilateral, first acute optic neuritis (AON) event consistent with inflammatory demyelinization, not explained by other etiologies. Onset of AON is defined by the presentation of visual disturbances.
- Able to provide written informed consent prior to enrollment
- Willing and able to comply with the protocol requirements for the duration of the study
For women of child bearing potential:
- A negative urine pregnancy test o
- Willing to practice an acceptable method of birth control •
- Willing to receive a steroidal regimen
Exclusion Criteria:
- A diagnosis of clinically definite multiple sclerosis (MS) (Clinically Definite Multiple Sclerosis)
- Current use of any approved disease modifying agents for treatment of MS
- Prior clinical episode of optic neuritis in either eye
- Bilateral AON
- Inability to undergo study evaluations in both eyes
- Known ocular or neurological conditions or abnormalities other than refractive error that impair visual function
- Retrogeniculate visual loss
- Refractive error of greater than +6 or -6 diopters
- Neuromyelitis Optica (Devic's disease)
- Systemic diseases that cause inflammatory optic neuropathy, including but not limited to Sarcoidosis, Systemic lupus erythematosus (SLE), Wegener's Granulomatosis, Syphilis, human immunodeficiency virus (HIV)
- Known ocular conditions that preclude dilation
- Any condition that may interfere with performance of Optical Coherence Tomography (OCT): corneal, lens or fundoscopic abnormality, a co-morbid ocular condition not related to optic neuritis as detected on the OCT reading
- Any condition that precludes administration of Glatiramer Acetate, such as a known history of sensitivity to mannitol
- Diabetes Mellitus Types I or II
- Gastric bypass surgery
- Current use of chemotherapy or radiotherapy
- Treatments that may cause visual loss such as plaquenil, anti-tubercular agents, interferon (IFN)-alpha therapy, monoclonal antibodies Cardiac medications that may affect visual evaluations such as digitalis, amiodarone, quinine
- Ongoing treatment with steroids (for longer than 10 days) within the last 3 months
- Significant or unstable medical, systemic, psychiatric or logistical condition that affects the patient's ability to give informed consent or to complete the study procedures
- Use of an investigational drug within 30 days prior to randomization
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Glatiramer acetate
Placebo
Arm Description
Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
Participants received placebo subcutaneous injection once a day for up to 6 months.
Outcomes
Primary Outcome Measures
Retinal Nerve Fiber Layer Thickness at 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.
Secondary Outcome Measures
To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters.
Full Information
NCT ID
NCT00856635
First Posted
March 4, 2009
Last Updated
January 8, 2018
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00856635
Brief 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). (Octagon)
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 Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
4. Oversight
5. Study Description
Brief Summary
The main objective of the study is to determine whether glatiramer acetate 20 mg once daily reduces the amount of axonal loss in the optic nerve after a first event of acute optic neuritis compared to placebo patients and to generate data supporting the potential neuroprotective effect of glatiramer acetate in a human in vivo model of axonal loss.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Neuritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glatiramer acetate
Arm Type
Experimental
Arm Description
Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo subcutaneous injection once a day for up to 6 months.
Intervention Type
Drug
Intervention Name(s)
Glatiramer Acetate
Other Intervention Name(s)
Copaxone
Intervention Description
20 mg injected daily subcutaneously
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
injected daily subcutaneously
Primary Outcome Measure Information:
Title
Retinal Nerve Fiber Layer Thickness at Baseline and Month 6
Description
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.
Time Frame
Baseline and Month 6
Secondary Outcome Measure Information:
Title
To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 18 - 45 years
Isolated, unilateral, first acute optic neuritis (AON) event consistent with inflammatory demyelinization, not explained by other etiologies. Onset of AON is defined by the presentation of visual disturbances.
Able to provide written informed consent prior to enrollment
Willing and able to comply with the protocol requirements for the duration of the study
For women of child bearing potential:
A negative urine pregnancy test o
Willing to practice an acceptable method of birth control •
Willing to receive a steroidal regimen
Exclusion Criteria:
A diagnosis of clinically definite multiple sclerosis (MS) (Clinically Definite Multiple Sclerosis)
Current use of any approved disease modifying agents for treatment of MS
Prior clinical episode of optic neuritis in either eye
Bilateral AON
Inability to undergo study evaluations in both eyes
Known ocular or neurological conditions or abnormalities other than refractive error that impair visual function
Retrogeniculate visual loss
Refractive error of greater than +6 or -6 diopters
Neuromyelitis Optica (Devic's disease)
Systemic diseases that cause inflammatory optic neuropathy, including but not limited to Sarcoidosis, Systemic lupus erythematosus (SLE), Wegener's Granulomatosis, Syphilis, human immunodeficiency virus (HIV)
Known ocular conditions that preclude dilation
Any condition that may interfere with performance of Optical Coherence Tomography (OCT): corneal, lens or fundoscopic abnormality, a co-morbid ocular condition not related to optic neuritis as detected on the OCT reading
Any condition that precludes administration of Glatiramer Acetate, such as a known history of sensitivity to mannitol
Diabetes Mellitus Types I or II
Gastric bypass surgery
Current use of chemotherapy or radiotherapy
Treatments that may cause visual loss such as plaquenil, anti-tubercular agents, interferon (IFN)-alpha therapy, monoclonal antibodies Cardiac medications that may affect visual evaluations such as digitalis, amiodarone, quinine
Ongoing treatment with steroids (for longer than 10 days) within the last 3 months
Significant or unstable medical, systemic, psychiatric or logistical condition that affects the patient's ability to give informed consent or to complete the study procedures
Use of an investigational drug within 30 days prior to randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J. Kupersmith, MD
Organizational Affiliation
Roosevelt Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Calabresi, MD
Organizational Affiliation
John Hopkins School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
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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