Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000181404
Ethics application status
Approved
Date submitted
18/03/2007
Date registered
26/03/2007
Date last updated
26/03/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of Memantine [N- Methyl- D- Aspartate (NMDA) receptor antagonist] versus placebo in acute non arteritic anterior ischemic optic neuropathy (NAION)
Scientific title
In patients with NAION (Non-arteritic anterior ischemic optic neuropathy), is Memantine as good as or better than placebo for improving visual functions?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non arteritic anterior ischemic optic neuropathy (NAION) 1699 0
Condition category
Condition code
Neurological 1792 1792 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intervention: Memantine tablets for treatment group for 3 weeks orally(5mg/day for the first week and 10 mg/ day for the next two weeks)
Intervention code [1] 1653 0
Treatment: Drugs
Comparator / control treatment
Placebo (lactose powder) for control group
Control group
Placebo

Outcomes
Primary outcome [1] 2511 0
Any change in visual acuity
Timepoint [1] 2511 0
Baseline, then on week 3, months 3 and 6
Secondary outcome [1] 4324 0
Any change of VEP (visual evoked potential) parameters (amplitude and latency) and automated perimetry parameters.
Timepoint [1] 4324 0
From baseline with month 3.

Eligibility
Key inclusion criteria
Unilateral acute onset of painless visual loss, localized or generalized edema and paleness of the optic nerve head, flame shaped hemorrhages, arterial narrowing without venous congestion and RAPD (relative afferent pupillary defect) in acute phase (=8 weeks) along with visual field defect consistent with non arteritic AION in perimetry.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy and breast feeding, complete optic disc atrophy that other etiologies were suggested, presence of systemic signs and symptoms such as fever, headache… consistent with arteritic AION, drug history such as anti-convulsants, barbiturates, neuroleptics, Amantadine hydrochlorothiazids and history of renal insufficiency.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation concealment by contacting the holder of the allocation who was off-site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
allocation was concealed by using dynamic random allocation (Minimisation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects, therapist or clinician, assessor, and data analyst were all masked
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment outside Australia
Country [1] 490 0
Iran, Islamic Republic Of
State/province [1] 490 0

Funding & Sponsors
Funding source category [1] 1942 0
University
Name [1] 1942 0
Ophthalmology department/ school of medicine/ Medical Sciences/ Tehran University
Country [1] 1942 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Tehran University of Medical sciences
Address
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 1756 0
None
Name [1] 1756 0
Nil
Address [1] 1756 0
Country [1] 1756 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3620 0
the investigational review board and ethics committees of Tehran University of Medical Sciences
Ethics committee address [1] 3620 0
Ethics committee country [1] 3620 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 3620 0
Approval date [1] 3620 0
Ethics approval number [1] 3620 0
214
Ethics committee name [2] 3621 0
Tehran University Eye Research Center
Ethics committee address [2] 3621 0
Ethics committee country [2] 3621 0
Iran, Islamic Republic Of
Date submitted for ethics approval [2] 3621 0
Approval date [2] 3621 0
Ethics approval number [2] 3621 0
214

Summary
Brief summary
Evaluation of the neuroprotective effect of Memantine in visual function of patients with acute NAION. Our hypothesis was that Memantine helps for better improvement of visual function in acute phase of NAION
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27756 0
Address 27756 0
Country 27756 0
Phone 27756 0
Fax 27756 0
Email 27756 0
Contact person for public queries
Name 10842 0
Mohammad Riazi-Esfahani MD
Address 10842 0
Farabi Eye Hospital, Qazvin Square, Tehran
Country 10842 0
Iran, Islamic Republic Of
Phone 10842 0
+98 9121446987
Fax 10842 0
+98 21 22678090
Email 10842 0
mriazi@sina.tums.ac.ir
Contact person for scientific queries
Name 1770 0
Mohammad Riazi-Esfahani MD
Address 1770 0
Farabi Eye Hospital
Qazvin Square
Tehran
Country 1770 0
Iran, Islamic Republic Of
Phone 1770 0
+98 9121446987
Fax 1770 0
+98 21 22678090
Email 1770 0
mriazi@sina.tums.ac.ir

No information has been provided regarding IPD availability


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No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
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