The VICI trial - investigating if the steroid Eplerenone can be used in the treatment of fluid build up in the eye caused by Central serous chorio-retinopathy

Phase 1

• Conditions: Central serous chorio-retinopathy; MedDRA version: 20.1Level: LLTClassification code 10007974Term: Central serous retinopathySystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2016-000113-70-GB
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-11
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

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
AND
b.characteristic appearance of CSCR on FFA and Indocyanine-green angiography (ICGA).
AND
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.
6.A study eye should have clear ocular media and adequate pupillary dilatation to permit photography.

* this includes: progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide cap, diaphragm or sponge with spermicide, combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal),
progestogen-only hormonal contraception associated with inhibition of ovulation: (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence.
NB pregnancy test only need to be repeated if there is reason to suspect the participant has become pregnant.
There are no special precautions/contraceptive requirements for male participants with female partners of child bearing potential.

It is rare but not impossible for patients to present with CSCR in both eyes or CSCR may develop in the fellow eye during the trial. We propose to measure eye-specific outcomes such as BCVA in both eyes throughout the trial, designating eyes as study eyes or not. Statistical analyses will take into account the availability of data for two eligible eyes in one patient.

If both eyes present with CSCR at baseline, the clinical trial site will decide which is the primary eye and this eye will have retinal imaging performed first. The primary eye would usually be the one with most active disease/most sub-retinal fluid. It will be identified by OCT imaging and subsequent investigations such as fluorescein and indocyanine green angiography will then be performed initially on this eye. If a patient presents with one affected eye and the fellow eye subsequently develops CSCR the eye first affected will always be the primary study eye.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 104
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

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.
10.Known hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
11. Patients receiving high doses of Aspirin (>75mg).

The following additional exclusions apply to a study eye only (i.e. they may be present for a non-study eye):

12.Evidence of choroidal neovascularization.
13.Previous or current treatment with eplerenone for any reason or previous or current treatment with photodynamic laser therapy / any anti-VEGF therapy in the study eye / any intra-ocular steroid use / thermal laser therapy for CSCR
14.Presence of any other disease which could cause retinal or SRF to accumulate e.g. diabetic retinopathy, polypoidal choroidal vasculopathy, domed shaped maculopathy or choroidal hemangioma or affect visual acuity.
15.Myopia > -6 dioptres

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified