<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20220423054621N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-24</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of oral eplerenone in the management of Acute Central Serous Chorioretinopathy</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of oral eplerenone in the management of Acute Central Serous Chorioretinopathy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-06-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68381</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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.</study_design>
      <phase>3</phase>
      <hc_freetext>Acute Central Serous Chorioretinopathy.</hc_freetext>
      <i_freetext>Intervention 1: 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. Intervention 2: 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.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mona Alvandimanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatullah Al-Azam Hospital, Mulla Sadra St., Vanak Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435915371</zip>
        <telephone>+98 921 241 8042</telephone>
        <email>Monaalvandimanesh@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mona Alvandimanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatullah Al-Azam Hospital, Mulla Sadra St., Vanak Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435915371</zip>
        <telephone>+98 921 241 8042</telephone>
        <email>Monaalvandimanesh@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of acute central serous chorioretinopathy before twelve weeks
Diagnosis of acute central serous chorioretinopathy for the first time</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <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)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H35.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Separation of retinal layers</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>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.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>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.</prim_outcome>
      <prim_outcome>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.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-13</approval_date>
        <contact_name>Ethics committee of baghiatallah University of Medical Sciences</contact_name>
        <contact_address>Vanak Sq Mollasadra Ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
