Clinical efficacy and mechanistic evaluation of Eplerenone for Central serous chorio-retinopathy – the VICI randomised trial. - VICI

niversity Hospital Southampton NHS Foundation Trust0 sites104 target enrollmentJune 11, 2020

Overview

No summary available.

Registry

who.int

Start Date

June 11, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity Hospital Southampton NHS Foundation Trust

•Participant may enter study if ALL of the following apply
•1\.Participants will be aged \=18 years and \= 60 years
•2\.Visual impairment due to CSCR of \= 4 months duration defined as:
•a.subfoveal presence of SRF on OCT
•b.characteristic appearance of CSCR on FFA and Indocyanine\-green angiography (ICGA).
•c.investigator believes that there is sufficient evidence from either patient history, case note documentation or appearance of the macula that CSCR has been present for at least 4 months.
•3\.Women must have a negative pregnancy test and be willing to use effective contraception\* for the duration of the participation in the trial and for 3 months after, be surgically sterile or post\-menopausal for \>12 months.
•4\.Able to provide written informed consent.
•The following apply to the study eye:
•5\.A study eye should have an Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA score greater than 53 letters and less than 86 letters.

•Participant may not enter study if ANY of the following apply
•1\.Hyperkalaemia (serum potassium level \> 5\.0 mmol/L).
•2\.Hepatic or renal impairment (Patients with severe renal insufficiency (Estimated glomerular filtration rate, eGFR \< 30 mL per minute per 1\.73 m2\) or Patients with severe hepatic insufficiency (Child\-Pugh Class C).
•3\.Pregnancy or breast feeding.
•4\.Known allergy to fluorescein or indocyanine green.
•5\.Patients receiving potassium\-sparing diuretics, potassium\-supplements, or inhibitors of CYP 3A4 (e.g.amiodarone, diltiazem, fluconazole, itraconazole, ketoconazole, ritonavir, nelfinavir, saquinavir clarithromycin, telithromycin, erythromycin, verapamil, spironolactone and nefazodone)).Patients taking furosemide are eligible.
•6\.Patients receiving nonsteroidal anti\-inflammatory drugs (NSAIDs) (e.g. ibuprofen, naproxen).
•7\.Patients receiving the combination of an angiotensin converting enzyme (ACE) inhibitor and an angiotensin receptor blocker (ARB) with eplerenone.
•8\.Patients receiving lithium, cyclosporine or tacrolimus.
•9\.Hypersensitivity or known allergy to eplerenone or to any of the excipients.