Phase 3
Completed N=44
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
Source: ClinicalTrials.gov NCT00856635 ↗
Enrolled (actual)
44
Serious AEs
2.5%
Results posted
Sep 2013
Primary outcomePrimary: Retinal Nerve Fiber Layer Thickness at Baseline and Month 6 — 128.1; 130.5; 89.5; 88.0 µm
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retinal Nerve Fiber Layer Thickness at Baseline and Month 6 |
128.1; 130.5; 89.5; 88.0 | — |
| SECONDARY To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters. |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT00856635). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.