Oral mineralocorticoid-receptor antagonist vs 0.3 % nepafenac for the treatment of acute central serous chorioretinopathy: a prospective, randomized comparative study
compare two treatments ( oral eplerenone and topical nepafenac) in the resolution of acute central serous chorioretinopathy
Design
Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site.
sample size 55 in each group, 110 in total.
Settings and conduct
Multicentric.
Pakistan.
Retina clinic of a tertiary care dedicated eye care setup.
The person assessing the scans of the retina and the technician who will assess the vision will be blinded. Trail statistician, data entries, technician, pharmacist and staff will be blinded.
Participants/Inclusion and exclusion criteria
Participants were eligible if they were aged 18-60 years with acute central serous chorioretinopathy.
Acute central serous chorioretinopathy was defined by the presence of subretinal fluid on optical coherence tomography (OCT) and visual symptoms for < 12 weeks’ duration.
Exclusion criteria were the presence of chronic central serous chorioretinopathy, duration of visual symptoms more than 12 weeks, diffuse retinal pigment epithelial changes or recurrent central serous chorioretinopathy , presence of choroidal neovascular membrane identified by OCT and confirmed on fundus angiography; any treatment for retinal disease (including intravitreal injections, photodynamic therapy, laser photocoagulation, vitrectomy), history of other retinal disorders (including age-related macular degeneration, diabetic retinopathy, uveitis or pathologic myopia).
Intervention groups
55 patients will be given topical nepafenac and 55 will be given oral eplerenone.
Main outcome variables
Resolution of visual acuity i.e. vision and the resolution of subretinal fluid as seen on the optical coherence tomography scans.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240404061413N1
Registration date:2024-05-01, 1403/02/12
Registration timing:registered_while_recruiting
Last update:2024-05-01, 1403/02/12
Update count:0
Registration date
2024-05-01, 1403/02/12
Registrant information
Name
Adnan Saleem
Name of organization / entity
Amanat Eye Hospital
Country
Pakistan
Phone
+92 51 8438021
Email address
doctoradnansaleem@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-15, 1403/01/27
Expected recruitment end date
2025-04-15, 1404/01/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Oral mineralocorticoid-receptor antagonist vs 0.3 % nepafenac for the treatment of acute central serous chorioretinopathy: a prospective, randomized comparative study
Public title
[comparing two treatments in resolving a retinal/eye disorder] Per oral Eplerenone and topical nepafenac are being compared in the treatment of central serous chorioretinopathy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
acute central serous chorioretinopathy
Exclusion criteria:
chronic central serous chorioretinopathy
contraindications to oral eplerenone or topical nepafenac
retinal or choroidal pathologies
severe ocular disease
Age
From 18 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned (1:1) to either the 50 mg eplerenone (Epler- Platinum Pharmaceuticals) or 0.3 % nepafenac (Ilevro–Novartis) group by a trial statistician through a password-protected system online. Allocation was stratified by best corrected visual acuity and hospital(s).
All participants, care teams, outcome assessors, pharmacists, and members of the trial management group were masked to the treatment allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
Prescribing surgeon/doctor, optometrist assessing visual acuity, pharmacists (enclosed coded box of same dimensions), retinal scan technician were masked to the treatment allocation.
The person assessing the primary and secondary outcomes would not be aware what treatment has been given to the patients.
Oral eplerenone is taken per oral whereas nepafenac is being given topically. Both are effective treatments in acute central serous chorioretinopathy.
Both interventions have different routes of administration. Eplerenone is a tablet whereas nepafenac a drop formulation.
The main study team are blind to the participants chosen treatment. the trial statistician who wasn't involved in data collection has information on allocated treatment for the ethics committee and monitoring.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Al-Shifa trust eye hospital
Street address
jhelum road rawalpindi
City
Rawalpindi
Postal code
42000
Approval date
2023-12-01, 1402/09/10
Ethics committee reference number
ASTEH 2023/02/101
Health conditions studied
1
Description of health condition studied
Acute central serous retinopathy in a eye retinal disorder which involves by serous retinal detachment (SRD) due to one or more leakage areas from the choroid through a defect in the retinal pigment epithelium (RPE), and a dome shaped serous pigment epithelial detachment (PEDs).
ICD-10 code
H35.71
ICD-10 code description
Central serous chorioretinopathy
Primary outcomes
1
Description
Primary outcome measures were best corrected visual acuity comparisons between the treatment group (oral eplerenone & topical nepafenac) in the study eye at every visit.
Timepoint
Before intervention and 6, 12 and 24 weeks after either intervention.
Method of measurement
optometrist/technician will measure the vision with a Snellen chart as letters read with prescription glasses , if any.
2
Description
Primary outcome measures were subretinal fluid height measurements between the treatment group (oral eplerenone & topical nepafenac) in the study eye at every visit.
Timepoint
Before intervention and 6, 12 and 24 weeks after either intervention.
Method of measurement
optical coherence tomography
3
Description
Primary outcome measures were sub-foveal choroidal thickness measurements between the treatment group (oral eplerenone & topical nepafenac) in the study eye at every visit.
Timepoint
Before intervention and 6, 12 and 24 weeks after either intervention.
Method of measurement
optical coherence tomography
Secondary outcomes
1
Description
Secondary outcome was serum potassium level evaluation in oral eplerenone group.
Timepoint
Before intervention and 6 weeks.
Method of measurement
Serum potassium levels will be measured with a lab kit at six weeks to assess any derangements.
2
Description
Secondary outcome were topical nepafenac drug tolerance evaluated at each visit.
Timepoint
Before intervention and 6, 12 , 24 weeks after either intervention
Method of measurement
Slit lamp examination will be done to determine any possible side effects related to topical nepafenac (primarily corneal and conjunctival side effects)
Intervention groups
1
Description
Intervention group:1. Oral eplerenone 50 mg in two divided doses (25 mg tablet twice day)12 hours apart for 6 weeks will be given. Medicine taken after meals at the same time each day. Epler (platinum pharma, Pakistan)
Category
Treatment - Drugs
2
Description
Intervention group: 2. Topical nepafenac 0.3 % will be given. one drop in the morning in the affected eye in the lower cul de sac. Patient will be advised to keep the eye closed for 30 seconds. Nevanac 0.3 % eye drops by Alcon/Novartis Group USA.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Shifa Trust Eye hospital
Full name of responsible person
Ahmad Hasan Alizai
Street address
Jhelum road
City
Rawalpindi
Postal code
42000
Phone
+92 321 5180996
Email
alizai111@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alshifa trust eye hospital
Full name of responsible person
Ahmad hasan alizai
Street address
jhelum road
City
rawalpindi
Postal code
42000
Phone
+92 321 5180996
Email
alizai111@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alshifa trust eye hospital
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
Alshifa trust eye hospital
Full name of responsible person
Ahmad hasan alizai
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
jhelum road
City
rawalpindi
Province
punjab
Postal code
42000
Phone
+92 321 5180996
Email
alizai111@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alshifa trust eye hospital
Full name of responsible person
Ahmad hasan alizai
Position
AP
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
jhelum road
City
rawalpindi
Province
punjab
Postal code
42000
Phone
+92 321 5180996
Email
alizai111@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Alshifa trust eye hospital
Full name of responsible person
Ahmad hasan alizai
Position
AP
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
jhelum road
City
rawalpindi
Province
punjab
Postal code
42000
Phone
+92 321 5180996
Email
alizai111@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD