determination of eplerenone treatment efficacy in CSR patients
Design
Interventional study with control group, Two blinded, randomized, Factorial groups, 40 patients
Settings and conduct
Patients with CSR were randmoly (two blinded) divided into "treatment with eplrenon" and placebo groups. in treatment group, for first week 25 and for next 3 weeks 50mg eplrenon was administered.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Acute onset of disease (less than 3 months)
without history of previous treatments including treatment with drugs, PDT, Photocuagulation LASER
absence of choroidal neovascularization, polypoidal choroidal vasculopathy
absence of any pathology and impaired vision in other eye
absence of ophthalmic eye pathology such as Glaucoma, Retinal disease and uveitis
not taking corticostroids agents
normal kidney lab tests for "treatment" group
Intervention groups
Patients with Central Serous Chorioretinopathy which take eplerenone treatment (50mg/daily for the first week and then 25mg/daily for the net three weeks)
Patients with Central Serous Chorioretinopathy which take placebo treatment (every day one placebo)
Main outcome variables
Best corrected visual acuity; central macular thickness; macular volume; choroid thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180825040860N1
Registration date:2019-09-28, 1398/07/06
Registration timing:registered_while_recruiting
Last update:2019-09-28, 1398/07/06
Update count:0
Registration date
2019-09-28, 1398/07/06
Registrant information
Name
Hamidreza Jahanbani-Ardakani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3222 5034
Email address
hamidreza_jahanbaniardakani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Eplerenon drug in patient with Acute CSCR (Central SerousChorioretinopathy)
Public title
The efficacy of Eplerenon drug in patient with Acute CSCR (Central SerousChorioretinopathy)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute onset of disease (less than 3 months)
without history of previous treatments including treatment with drugs, PDT, Photocuagulation LASER
absence of any pathology and impaired vision in other eye
absence of ophthalmic eye pathology such as Glaucoma, Retinal disease and uveitis
not taking corticostroids agents
normal kidney lab tests for "treatment" group
having consent to participating in study
Exclusion criteria:
does not having Consent to participating in study
Younger than 18 years old
suffering from any ocular or kidney disease
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
we divided patients randomly (with Dr.Saghaei's software) into 2 groups; 20 participants in "treatment group" and 20 participants in "placebo group".
Blinding (investigator's opinion)
Double blinded
Blinding description
In the current study, neither patients nor physicians were not aware that every patient has been categorized in the treatment group or placebo group. The participating individuals were randomely categorized in treatment or placebo groups by using Dr. Saghaei software.
after diagnosis, the patients were randomly divided into two groups (Placebo/treatment). the physician does not know the patients are in which group during visiting and follow-up. also none of the patients knows their classification until end of study.
After the disease was diagnosed by specialist and resident of ophthalmology, participants were referred to secretory an he/she delivered placebo or drug to participants. In following up visits, results of tests were gathered by secretory and after doing anonymously, the results were delivered to an epidemiologist. after analysis, it was cleared that each data and analysis were related to each group. All of the patients were awarded regarding their classification (placebo or treatment group) after the study was done.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sceinces
Street address
Hezar Jareeb str., Azadi Sqr.
City
Isfahan
Province
Isfehan
Postal code
8974673461
Approval date
2019-02-17, 1397/11/28
Ethics committee reference number
IR.MUI.MED.REC.1397.242
Health conditions studied
1
Description of health condition studied
Central Serous Chorioretinopathy
ICD-10 code
H35.71
ICD-10 code description
Central serous chorioretinopathy
Primary outcomes
1
Description
Best Corrected visual aquity
Timepoint
before and one month after initiation of intervention
Method of measurement
snellen chart
2
Description
Central macular thickness
Timepoint
before and one month after initiation of intervention
Method of measurement
optical coherence topogrphy
3
Description
Macular volume
Timepoint
before and one month after initiation of intervention
Method of measurement
optical coherence topogrphy
4
Description
Choroidal thickness
Timepoint
before and one month after initiation of intervention
Method of measurement
optical coherence topogrphy
Secondary outcomes
1
Description
adverse effects of eplerenon
Timepoint
during intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: for patients of treatment group, Eplerenon was initiated. in the first week, 25 mg daily and for the three next weeks, 50 mg daily was administered.
Category
Treatment - Drugs
2
Description
Control group: for patients of control group, placebo was administered for 4 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz eye hospital
Full name of responsible person
Alireza Dehghani
Street address
Qods square; feiz eye hospital
City
Isfahan
Province
Isfehan
Postal code
8149644874
Phone
+98 31 3445 2031
Email
dehghani@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Azadi Square, Hezar Jareeb Street, Esfahan University of Medical Sciences, Building No. 4
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5149
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Tohidi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Feiz Eye Hospital, Qods Sq, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8149644874
Phone
+98 31 3445 2031
Email
dr.tohidi1387@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Dehghani
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Feiz Eye Hospital, Qods Sq., Isfahan
City
ISfahan
Province
Isfehan
Postal code
8149644874
Phone
+98 31 3445 2031
Email
dehghani@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Jahanbani Ardakani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Feiz Eye Hospital, Qods Sq., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8149644874
Phone
+98 31 3445 2031
Email
hamidreza_jahanbaniardakani@yahoo.com
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