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)

Optic Neuritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856635
• Other study ID #: PM030
• Status: Completed
• Phase: Phase 3
• First received: March 4, 2009
• Last updated: January 8, 2018
• Start date: February 2009
• Est. completion date: February 2011

Study information

• Verified date: January 2018
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuritis
• Optic Neuritis

Intervention

Drug:
• Glatiramer Acetate
20 mg injected daily subcutaneously
• placebo
injected daily subcutaneously

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Month 6
Secondary	To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters.		6 months