Randomized Control Trial of Comparing Spironolactone versus Placebo on Sub Retinal Fluid Thickness and Best Correct visual Acuity of Patients with Chronic Central Serous Chorioretinopathy
Study will be done in patients with chronic central serous chorioretinopathy from 5 referral hospitals. From these patients who other causes of this clinical feature roll out about them and have symptomatic subretinal fluid (SRF) at least for 3 months and do not like to treat with photodynamic therapy and do not have any contraindications to take Spironolactone will be enrolled. Patients will be randomly divided into two groups that receive drug (spironolactone) or placebo according to block randomization (block sizes are 4 and 6). Sample size is 25 patients in each group . Drug and placebo are definitely the same in the shape, size and pack so the patients and ophthalmologist are blind to intervention. Then patients will take drug or placebo twice a day and will be followed for 3 months and during this period have 3 examinations on 1st and 30th and 90th days. Evaluation will be based on: slit lamp Examination,Optical Coherence Tomography (OCT) imaging, Best Corrected Visual Acuity (BCVA) , on first day, one and three months. Fluorescein angiography on first day, and three months after initiation of treatment. Main outcome measures are subretinal fluid thickness and BCVA.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092224140N1
Registration date:2015-12-20, 1394/09/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-20, 1394/09/29
Registrant information
Name
Khalil Ghasemi Falavarjani
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9162
Email address
ghasemif.kh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Accepted in national network of ophthalmic research.
Expected recruitment start date
2015-10-21, 1394/07/29
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized Control Trial of Comparing Spironolactone versus Placebo on Sub Retinal Fluid Thickness and Best Correct visual Acuity of Patients with Chronic Central Serous Chorioretinopathy
Public title
Spironolactone in the treatment of chronic central serous chorioretinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
1. At least 3 months after CSC (according to OCT without SRF decrease of 10% and symptoms for at least 3 months) (chronic changes:pigmentory changes or central macular edema)
2. Do not take any treatment
3. Subfoveal leak and SRF in macula
4. Do not want to do PDT NO pregnancy and breastfeeding
5. NO any ocular pathology other than refractive disorders
6. NO Addison's disease
7. NO hyperkalemia
8. NO oliguria
9. NO acute renal failure
10. Do not take eplerenone
11. Do not take diuretics
12. Do not taking angiotensin-converting enzyme inhibitors
13. Do not take angiotensin receptor blockers
14. Do not take aldosterone inhibitors comets
15. Do not take NSAIDs
16. Do not take heparin or low molecular weight heparin
17. NO high-potassium diet
18. Do not take exogenous potassium
19. Do not take barbiturates
20. Do not have alcohol Consumption
21. Do not use narcotics
22. Do not take lithium
23. Do not use corticosteroid
24. Do not use ACTH
25. Do not take digoxin
26. Do not have Diabetes
27. Do not have eye surgery in three months
28. No Sensitivity to Fluorescein or Indocyanine
29. No hepatic impairment
30. Do not use of contraception methods in women of childbearing age.
31.In cases where the OCT during the first three months of the SRF is less than 10% of patient
Exclusion criteria:
1. If patients do not follow according to protocol.
2.If drug complication appear such as : headache or gastrointestinal symptoms.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Farabi hospital, Tehran University of Medical Sciences.
Street address
Enghelab St., Qazvin Sq., Farabi hospital
City
Tehran
Postal code
Approval date
2015-08-26, 1394/06/04
Ethics committee reference number
IR.TUMS.FARABIH.REC-1394.2
Health conditions studied
1
Description of health condition studied
Chronic Central Serous Chorioretinopathy
ICD-10 code
H35.7
ICD-10 code description
Central serous chorioretinopathy Detachment of retinal pigment epithelium
Primary outcomes
1
Description
Best corrected visual acuity
Timepoint
One month and 3 months after treatment
Method of measurement
By snellen chart
2
Description
Subretinal fluid thickness
Timepoint
One month and 3 months after treatment
Method of measurement
Optical Coherence Tomography (OCT)
Secondary outcomes
empty
Intervention groups
1
Description
Spironolactone , 25mg, BD, for 3 months
Category
Treatment - Drugs
2
Description
Placebo, BD, for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi hospital (Tehran University of Medical Sciences)
Full name of responsible person
Dr. Alireza Khodabandeh
Street address
Enghelab St., Qazvin Sq., Farabi hospital
City
Tehran
2
Recruitment center
Name of recruitment center
Torfeh hospital (Shaihd Beheshti University of Medical Sciences)
Full name of responsible person
Dr. Homayoon Nikkhah
Street address
Baharestan St., Baharestan Sq., Torfeh hospital.
City
Tehran
3
Recruitment center
Name of recruitment center
Khatam al anbia hospital (Mashhad University of Medical Sciences)
Full name of responsible person
Dr. Nasser Shoaibi
Street address
Kolahdooz Blvd., Abutaleb Crossroad, Khatam al anbia hospital
City
Mashhad
4
Recruitment center
Name of recruitment center
Labafinejad hospital (Shaihd beheshti University of Medical Sciences)