Specialty: Ophthalmology, Primary sub-specialty: Glaucoma
Conditions
Interventions
Patients who consent will be randomised using an online system to active drug (Eplerenone) or placebo. They will be given a 25-mg dose (tablet form) for 1 week, reviewed and if tolerated the dose will
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria as of 12/01/2017: 1. Aged between 18 and 60 years 2. Visual impairment due to CSCR of = 4 months duration defined as: 2.1. Subfoveal presence of SRF on OCT AND 2.2. Characteristic appearance of CSCR on FFA and Indocyanine-green angiography (ICGA). AND 2.3. Investigator believes that there is sufficient evidence from patient history, case note documentation or appearance of the macula that CSCR has been present for at least 4 months 3. Women must be willing to use effective contraception, be surgically sterile or post-menopausal for >12 months 4. Able to provide written informed consent The following additional inclusions apply to a study eye only (i.e. they may be present for a non-study eye): 1. A study eye should have an Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA score greater than 53 letters and less than 86 letters 2. A study eye should have clear ocular media and adequate pupillary dilatation to permit photography 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 subretinal 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. Original inclusion criteria: 1. Aged between 18 and 60 years 2. Visual impairment due to central serous chorio-retinopathy (CSCR) of = 4 months duration defined as: 2.1. Subfoveal presence of sub-retinal fluid (SRF) on OCT AND 2.2. Characteristic appearance of CSCR on FFA and Indocyanine-green angiography (ICGA). 3. Women must be willing to use effective contraception, be surgically sterile or post-menopausal for >12 months 4. Able to provide written informed consent The following additional inclusions apply to a study eye only (i.e. they may be present for a non-study eye): 5. A study eye should have an Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA score greater than 53 letters and less than 79 letters 6. A study eye should have clear ocular media and adequate pupillary dilatation to permit photography 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 subretinal fluid. It will be identified by OCT imaging and subsequent investigations such as fluorescein and indocyanine green angiography will then be performed
Exclusion criteria
Exclusion criteria: Exclusion criteria as of 12/01/2017: 1. Hyperkalaemia (serum potassium level > 5.0 mmol/L) 2. Hepatic or renal impairment (Patients with severe renal insufficiency (Estimated glomerular filtration rate, eGFR 75mg) 8. Patients receiving nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g. ibuprofen, naproxen). 9. Patients receiving lithium, cyclosporine or tacrolimus. 10. Hypersensitivity or known allergy to eplerenone or to any of the excipients. 11. Known hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. The following additional exclusions apply to a study eye only (i.e. they may be present for a non-study eye): 1. Evidence of choroidal neovascularization 2. 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 3. Presence of any other disease which could cause retinal fluid or SRF to accumulate (e.g. diabetic retinopathy, polypoidal choroidal vasculopathy, domed shaped maculopathy or choroidal haemangioma) or affect visual acuity 4. Myopia > -6 dioptres Original exclusion criteria: 1. Hyperkalaemia (serum potassium level > 5.0 mmol/L) 2. Concomitant use of potassium-sparing diuretics or potassium supplements 3. Hepatic or renal impairment (Patients with severe renal insufficiency (Estimated glomerular filtration rate, eGFR -6 dioptres
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome as of 23/01/2017: Best Corrected Visual Acuity measured using validated ETDRS vision charts, at the 12 month visit, adjusted for baseline BCVA. Original primary outcome: The change in Best Corrected Visual Acuity measured using validated ETDRS vision testing at baseline, 4 weeks, 3, 6, 9 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcomes as of 05/03/2019: 1. Low luminance BCVA. This is measured immediately after measuring BCVA by adding a 2 log neutral density filter and recording the number of letters read. 2. CSRT as measured by OCT recorded at 12 months, including CSRT measured at interim visits and adjusted for baseline CSRT. 3. Change in sub-retinal fluid thickness as measured by OCT 4. Systemic and ocular adverse events at any time during the 12 month follow-up period 5. Proportion of patients with macular atrophy of the RPE defined as hypoautofluorescence at 12 months 6. Area change in macular RPE hypoautofluorescence at 12 months. 7. Choroidal thickness as measured by enhanced depth imaging OCT at 12 months, adjusted for baseline choroidal thickness. Measurements to be made sub-foveally. 8. Proportion of patients with reduced choroidal permeability on ICG at 12 months 9. Time to resolution of SRF. 10. Classification of all study eyes as complete, partial or no resolution of SRF at each time point of the study. Partial resolution of SRF is defined as a decrease of >25 % of CMT from baseline. A non-responder is defined as having an increase in SRF or decrease in SRF =25% from baseline. 11. Patient-reported visual function using Visual Function Questionnaire VFQ 25 will be assessed at baseline and 12 months. 12. Classification of all study eyes by each FFA phenotype, such as smoke stack, ink-blot and chronic epitheliopathy at baseline and 12 months. 13. Classification of all study eyes as early, late, or non responder. An early responder is defined as complete or partial resolution of sub-foveal SRF by 3 months. A late responder is defined as complete or partial resolution of sub-foveal SRF after 6 months. 14. Incidence of CSCR in the fellow eye as measured by OCT, FFA, ICGA or AF. 15. Time to recurrence of SRF. Recurrence will be defined as the appearance of new SRF in a study eye after complete resolution of SRF at any point. Previous secondary outcomes as of 05/ | — |
Countries
England, Northern Ireland, United Kingdom
Contacts
Public ContactAndrew Lotery
Outcome results
None listed