1. Home
  2. Approved trials
  3. » فارسی

Evaluation of the effect of oral eplerenone in the management of Acute Central Serous Chorioretinopathy

Protocol summary

Study aim
Evaluation of the effect of oral eplerenone in the management of Acute Central Serous Chorioretinopathy
Design
A clinical trial with a control group, with parallel groups, single-blind, randomized, phase 3 on about 36 patients.
Settings and conduct
Patients who refer to Baqiyatullah Clinic due to acute central serous chorioretinopathy will be included in the study according to the entry and exit criteria. Patients will be randomly divided into intervention and control groups. At first, each patient will undergo visual acuity evaluation and SD-OCT and clinical examinations. The intervention group treated with eplerenone and the control group will receive Eye vit plus tablets. Patients will be followed up in 1, 2, 3 months after the start of treatment by measuring BCVA and SD-OCT. Whenever the disease improves during the treatment period, the drug will be discontinued. Then the measured data in two groups of case and control are analyzed and compared with appropriate statistical tests.
Participants/Inclusion and exclusion criteria
Acute central serous chorioretinopathy before twelve weeks Acute central serous chorioretinopathy for the first time
Intervention groups
Intervention group: Patients in the case group will be treated with eplerenone oral tablets, at the rate of 50 mg per day for 12 weeks. Follow-up of patients in 1, 2, 3 months after the start of treatment will be done by measuring BCVA and SD-OCT. Whenever the disease improves during the treatment period, the drug will be discontinued. Control group: Patients of the case group will be treated with eye vit plus oral tablets, one tablet daily for 12 weeks. The follow-up of the patients will be the same as the intervention group.
Main outcome variables
Primary outcome measures will include comparison of BCVA, SD-OCT and clinical examinations between treatment and control groups and at all time points.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220423054621N1
Registration date: 2024-06-24, 1403/04/04
Registration timing: prospective

Last update: 2024-06-24, 1403/04/04
Update count: 0
Registration date
2024-06-24, 1403/04/04
Registrant information
Name
mona alvandimanesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 921 241 8042
Email address
monaalvandimanesh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-29, 1403/04/09
Expected recruitment end date
2024-09-04, 1403/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral eplerenone in the management of Acute Central Serous Chorioretinopathy
Public title
Evaluation of the effect of oral eplerenone in the management of Acute Central Serous Chorioretinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of acute central serous chorioretinopathy before twelve weeks Diagnosis of acute central serous chorioretinopathy for the first time
Exclusion criteria:
Chronic CSCR (duration of visual symptoms more than 12 weeks) Recurrent CSCR (patients with a history of one or more previous CSCR attacks) Choroidal neovascularization (CNV) detected by FA, ​​ICGA, or OCT angiography (OCT-A) Any treatment for retinal disease (including intravitreal injections, photodynamic therapy, laser photocoagulation, vitrectomy) History of other retinal disorders (including age-related macular degeneration, choroidal neovascularization, diabetic retinopathy, uveitis, or pathological myopia) The presence of any other systemic disease for which eplerenone is contraindicated (such as severe renal, cardiac or hepatic failure, pregnancy, baseline serum potassium more than 0.5 mEq/L simultaneous administration of potassium-sparing diuretics, potassium supplements, inhibitors angiotensin converting enzyme or angiotensin receptor blockers)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be done using the random blocking method (blocks of four). The possible blocks are as follows: 1- AABB, 2- ABAB, 3- BABA, 4- BBAA, 5- BAAB, 6- ABBA. In this step, numbers (1 to 6) will be randomly selected using the table of random numbers. and this work is repeated 10 times until the sample volume is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
The drugs of the two groups will be similar in terms of shape, color and packaging (the pharmaceutical company has been asked to make a placebo in the same packaging as the drug under study) and the patients and also the person evaluating the consequences of the status of assignment to the treatment groups And they will not know the hypothesis of the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of baghiatallah University of Medical Sciences
Street address
Vanak Sq Mollasadra Ave
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2024-01-13, 1402/10/23
Ethics committee reference number
IR.BMSU.BAQ.REC.1402.088

Health conditions studied

1

Description of health condition studied
Acute Central Serous Chorioretinopathy
ICD-10 code
H35.7
ICD-10 code description
Separation of retinal layers

Primary outcomes

1

Description
Best corrected visual acuity (BCVA)
Timepoint
At the beginning of the study, one month, two months and three months later
Method of measurement
Tumbling E” eye chart

2

Description
Central Macular Thickness (CMT)
Timepoint
At the beginning of the study, one month, two months and three months later
Method of measurement
Use of SD-OCT device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in the case group will be treated with eplerenone oral tablets, at the rate of 50 mg per day for 12 weeks. Follow-up of patients in 1, 2, 3 months after the start of treatment will be done by measuring BCVA and SD-OCT. Whenever the disease improves during the treatment period, the drug will be discontinued.
Category
Treatment - Drugs

2

Description
Control group: The patients of the case group will be treated with eye vit plus oral tablets (OPD Pharma), one pill per day for 12 weeks. Follow-up of patients in 1, 2, 3 months after the start of treatment will be done by measuring BCVA and SD-OCT. Whenever the disease improves during the treatment period, the drug will be discontinued.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyat Allah Clinic
Full name of responsible person
Mona Alvandimanesh
Street address
Baqiyatullah Al-Azam Hospital ,Mulla Sadra St. , Vanak Square
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 85554
Email
Dr.Samadinia@bmsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr Nematollah Jonaidi
Street address
Baqiyatullah Al-Azam Hospital, Mulla Sadra St., Vanak Square
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 85554
Email
dr.samadinia@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mona Alvandimanesh
Position
Ophthamology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Baqiyatullah Al-Azam Hospital, Mulla Sadra St., Vanak Square
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 921 241 8042
Email
Monaalvandimanesh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mona Alvandimanesh
Position
Ophthamology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Baqiyatullah Al-Azam Hospital, Mulla Sadra St., Vanak Square
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 921 241 8042
Email
Monaalvandimanesh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mona Alvandimanesh
Position
Ophthamology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Baqiyatullah Al-Azam Hospital, Mulla Sadra St., Vanak Square
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 921 241 8042
Email
Monaalvandimanesh@gmail.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
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Access to the data is possible immediately after the result is determined
To whom data/document is available
The data will be available to researchers
Under which criteria data/document could be used
The information can be used for further study and research
From where data/document is obtainable
Responsible for the project's scientific information monaalvandimanesh@gmail.com
What processes are involved for a request to access data/document
After sending the request, the information will be available to the applicant within three days
Comments
Loading...