Determining the effect of fampiridine on visual parameters and optic nerve imaging in patients with anterior ischemic optic neuropathy.
Design
A controlled, parallel-group, no blinded, randomized phase 3 clinical trial on 40 patients. The envelope method will be used for randomization.
Settings and conduct
This study will be conducted at Shahid Beheshti University of Medical Sciences Institute of Eye and Vision Sciences on patients with anterior ischemic optic neuropathy. A group of patients receive only routine care. In addition to routine care, the second group will receive 10 mg fampiridine tablets for 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with anterior ischemic optic neuropathy; Consent to participate in the study; At least 3 months have passed since the onset of symptoms
No inclusion criteria: Pregnancy; History of seizures; Renal failure
Intervention groups
Intervention group: In addition to standard treatment and control of underlying risk factors such as diabetes and blood pressure, they will be treated with 10 mg fampiridine tablets for 12 weeks (one tablet every 12 hours, the first week and 2 tablets from the second week onwards).
Control group: They will receive only standard treatment and control of underlying risk factors such as diabetes and blood pressure
Main outcome variables
Changes in optic nerve cell thickness, visual parameters and optic nerve imaging
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N35
Registration date:2024-02-07, 1402/11/18
Registration timing:prospective
Last update:2024-02-07, 1402/11/18
Update count:0
Registration date
2024-02-07, 1402/11/18
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Fampiridine on visual parameters and optic nerve imaging in patients with Anterior Ischemic Optic neuropathy
Public title
The effect of fampiridine on optic nerve imaging in patients with Anterior Ischemic Optic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with anterior ischemic optic neuropathy
Consent to participate in the study
At least 3 months have passed since the onset of symptoms
Exclusion criteria:
Pregnancy
History of seizures
Renal failure
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
40 cards will be prepared, 20 cards with letter I (meaning intervention) and 20 cards with letter C (meaning control) and each one is placed in an envelope with aluminum foil and the lid is glued and placed inside a box. to give At the time of patients' arrival, one of the letter envelopes will be randomly selected and opened. According to the selected letter, the patient will be assigned to the intervention or non-intervention group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Next to Taleghani Hospital, Shahid Abbas Arabi Street (Parvaneh), Yemen Street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2023-07-17, 1402/04/26
Ethics committee reference number
IR.SBMU.ORC.1402.006
Health conditions studied
1
Description of health condition studied
Anterior Ischemic Optic neuropathy
ICD-10 code
H47.01
ICD-10 code description
Ischemic optic neuropathy
Primary outcomes
1
Description
Acuity Visual
Timepoint
Pre treatment and 12 weeks post treatment
Method of measurement
Using ETDRS chart
2
Description
Field of vision
Timepoint
Pre treatment and 12 weeks post treatment
Method of measurement
Using automatic perimetry device
Secondary outcomes
1
Description
Change inthickness of nerve cells
Timepoint
Pre treatment and 12 weeks post treatment.
Method of measurement
Using Peripapillary-OCT
Intervention groups
1
Description
Intervention group: In addition to standard treatment and control of underlying risk factors such as diabetes and blood pressure, they will be treated with 10 mg fampiridine tablets for 12 weeks (one tablet every 12 hours, the first week and 2 tablets from the second week onwards).
Category
Treatment - Drugs
2
Description
Control group: They will receive only standard treatment and control of underlying risk factors such as diabetes and blood pressure