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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00856635
First received: March 4, 2009
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Optic Neuritis
Drug: Glatiramer Acetate
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Retinal Nerve Fiber Layer Thickness at Baseline and Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: February 2009
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: placebo
injected daily subcutaneously

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856635

Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Principal Investigator: Mark J. Kupersmith, MD Roosevelt Hospital
Principal Investigator: Peter Calabresi, MD John Hopkins School of Medicine
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00856635     History of Changes
Other Study ID Numbers: PM030
Study First Received: March 4, 2009
Results First Received: July 11, 2013
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Optic Neuritis
Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on October 01, 2014