Determination of the effect of Pleuron in patients with chronic central serous chorioretinopathy (CSCR)
Design
In this study, patients will be randomly assigned to two groups of 17: treatment (administration of eplerenone) and control (placebo of neutral drug). Will be prescribed weekly. In the control group, placebo will be prescribed for 4 weeks.
Settings and conduct
Imam Khomeini Hospital In this study, patients were randomly assigned to two groups of 17 (treatment with Eplerenone) and control (placebo of neutral drug) and after the disease was diagnosed by an ophthalmologist, participants received medication or The placebo will be referred to the secretary and he (medicine or placebo) will be delivered to the patients in two groups. For patients in the intervention group, Eplerenone will be administered at a dose of 25 mg for one week and then at a dose of 50 mg for three weeks. In the control group, placebo will be prescribed for 4 weeks.
Participants/Inclusion and exclusion criteria
Acute onset of the disease (less than 3 months) No previous treatment, no pathology, no vision, normal kidney tests and exclusion criteria: renal and hepatic impairment, or known allergy to any of the components of the drug
Intervention groups
Patients in the intervention group will be prescribed Eplerenone at a dose of 25 mg for one week and then at a dose of 50 mg for three weeks. In the control group, placebo will be prescribed for 4 weeks.
Main outcome variables
Best modified vision, central macular thickness, macular volume, choroid thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220122053792N1
Registration date:2022-03-06, 1400/12/15
Registration timing:registered_while_recruiting
Last update:2022-03-06, 1400/12/15
Update count:0
Registration date
2022-03-06, 1400/12/15
Registrant information
Name
Qader Motarjemizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
motarjemizadeh.q@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-15, 1400/10/25
Expected recruitment end date
2022-07-16, 1401/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Eplerenone in Central serous chorioretinopathy )CSCR
Public title
Evaluation of the effect of Eplerenone in Central serous chorioretinopathy )CSCR
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic central serous chorioretinopathy
Exclusion criteria:
Elevated potassium levels in preoperative blood testsor
contraindications in comprehensive medical examination
renal impairment
severe hepatic impairment
known allergies to any of the components of the drug
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients will be randomly divided into two groups of treatment (administration of Eplerenone) and control (placebo of neutral drug) with random allocation software (Random Allocation software).
Blinding (investigator's opinion)
Double blinded
Blinding description
606 / 5,000
Translation results
In the present study, patients and the treatment team (physicians) had no knowledge that each patient was in the treatment group or placebo group. Patients will be divided into two groups of treatment or placebo based on randomization after their disease is diagnosed. Then, without knowing which group each patient is in, the researcher will enter the patient in the study and the relevant treatment will be started and will be visited for follow-up in the future. Patients also do not know which group they belong to until the end of the study period. After the person is diagnosed with the disease by an ophthalmologist, participants are referred to a secretary for medication or a placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urmia University of Medical Sciences
Street address
Imam Khomeini University Hospital-Ershad AVE-Modarres Blvd- Urmia-IRAN
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Approval date
2022-01-15, 1400/10/25
Ethics committee reference number
IR.UMSU.REC.1400.407
Health conditions studied
1
Description of health condition studied
Chronic central serous chorioretinopathy
ICD-10 code
H35.71
ICD-10 code description
Central serous chorioretinopathy
Primary outcomes
1
Description
The patient's best corrected vision
Timepoint
Before and one month after the start of the intervention
Method of measurement
snellen chart
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:For patients in the intervention group, Eplerenone will be administered at a dose of 25 mg for one week and then at a dose of 50 mg for three weeks.
Category
Treatment - Drugs
2
Description
Control group: In the control group, placebo will be prescribed for 4 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia University of Medical Sciences Imam Khomeini Hospital
Full name of responsible person
Dr. Qader Motarjemizadeh
Street address
Imam Khomeini University Hospital-Ershad AVE-Modarres Blvd- Urmia-IRAN
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Fax
+98 44 3345 7277
Email
Motarjemizadeh.q@Umsu.ac.ir
Web page address
http://Imam.Umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Saber Gholizadeh
Street address
Urmia, Resalat Blvd., Emergency Alley, West Azerbaijan University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3346 9931
Email
saber@umsu.ac.ir
Web page address
http://Imam.umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Qader Motarjemizadeh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Imam Khomeini University Hospital-Ershad AVE-Modarres Blvd- Urmia-IRAN
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
0984433469931
Email
Motarjemizadeh.q@umsu.ac.ir
Web page address
http://Imam.umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Qader Motarjemizadeh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Imam Khomeini University Hospital-Ershad AVE-Modarres Blvd- Urmia-IRAN
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Email
Motarjemizadeh.q@umsu.ac.ir
Web page address
http://Imam.Umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Qader Motarjemizadeh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Imam Khomeini University Hospital-Ershad AVE-Modarres Blvd- Urmia-IRAN
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Email
Motarjemizadeh.q@umsu.ac.ir
Web page address
http://Imam.Umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available