Eplerenone for chronic central serous chorioretinopathy in patients with active, previously untreated disease for more than 4 months (VICI): a randomised, double-blind, placebo-controlled trial

Andrew Lotery; Sobha Sivaprasad; Abby J O'Connell; Rosie A Harris; Lucy A Culliford; Lucy A Ellis; Angela Cree; Savita Madhusudan; Francine Behar-Cohen; Usha Chakravarthy; Tunde Peto; Chris A Rogers; Barnaby C Reeves

doi:10.1016/S0140-6736(19)32981-2

Eplerenone for chronic central serous chorioretinopathy in patients with active, previously untreated disease for more than 4 months (VICI): a randomised, double-blind, placebo-controlled trial

Andrew Lotery, Sobha Sivaprasad, Abby J O'Connell, Rosie A Harris, Lucy A Culliford, Lucy A Ellis, Angela Cree, Savita Madhusudan, Francine Behar-Cohen, Usha Chakravarthy, Tunde Peto, Chris A Rogers, Barnaby C Reeves

Research output: Contribution to journal › Article (Academic Journal) › peer-review

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Abstract

Background:
In chronic central serous chorioretinopathy (CSCR), fluid accumulates in the sub-retinal space. It is a common visually disabling condition in individuals of working age. There is no definitive treatment. Previous research suggests the mineralocorticoid receptor antagonist, eplerenone, is effective for treating CSCR but it is not licensed for this indication. We evaluated whether eplerenone is superior to placebo for treating chronic CSCR.

Methods:
We conducted a placebo-controlled parallel-group randomised trial in 22 United Kingdom hospitals. Participants were aged ≥18 and ≤60 years with treatment naïve CSCR for ≥4 months. Randomisation stratified by best-corrected visual acuity (BCVA) and hospital was performed online, with participants randomised to receive oral eplerenone (25 mg/day for one week, increasing to 50 mg/day for up to 12 months) plus usual care or placebo plus usual care. Participants, care teams, outcome assessors, pharmacists and the trial management group were masked. The primary outcome was BCVA at 12 months. All outcomes apart from safety were analysed on a modified intention-to-treat basis. The trial is registered: ISRCTN92746680.

Findings:
Between 11/01/2017 and 22/02/2018, 57 participants were randomised to eplerenone and 57 to placebo; 57 and 54 participants respectively were included in the final analysis. Modelled mean BCVA at 12 months in the placebo and eplerenone groups were 79.5 (SD 4.5) and 80.4 (SD 4.6) letters, with an adjusted estimated difference (eplerenone minus placebo) of 1.73 letters (95% confidence interval -1.12 to 4.57, p=0·24) at 12 months. Hyperkalaemia occurred in eight participants in each group (14%). No serious adverse events occurred in the eplerenone group; three unrelated serious adverse events occurred in the placebo group.

Interpretation:
Eplerenone was not superior to placebo in improving BCVA in people with chronic CSCR during 12 months follow-up.

Funding
Efficacy and Mechanism Evaluation Programme, National Institute for Health Research and Social Care.

Original language	English
Pages (from-to)	294-303
Number of pages	10
Journal	Lancet
Volume	395
Issue number	10220
Early online date	23 Jan 2020
DOIs	https://doi.org/10.1016/S0140-6736(19)32981-2
Publication status	Published - 25 Jan 2020

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BTC (Bristol Trials Centre)

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This is the author accepted manuscript (AAM). The final published version (version of record) is available online via Elsevier at https://doi.org/10.1016/S0140-6736(19)32981-2 . Please refer to any applicable terms of use of the publisher.
Accepted author manuscript, 386 KBLicence: CC BY-NC-ND
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This is the author accepted manuscript (AAM). The final published version (version of record) is available online via Elsevier at https://doi.org/10.1016/S0140-6736(19)32981-2 . Please refer to any applicable terms of use of the publisher.
Accepted author manuscript, 1.75 MBLicence: CC BY-NC-ND

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Lotery, A., Sivaprasad, S., O'Connell, A. J., Harris, R. A., Culliford, L. A., Ellis, L. A., Cree, A., Madhusudan, S., Behar-Cohen, F., Chakravarthy, U., Peto, T., Rogers, C. A., & Reeves, B. C. (2020). Eplerenone for chronic central serous chorioretinopathy in patients with active, previously untreated disease for more than 4 months (VICI): a randomised, double-blind, placebo-controlled trial. Lancet, 395(10220), 294-303. https://doi.org/10.1016/S0140-6736(19)32981-2

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title = "Eplerenone for chronic central serous chorioretinopathy in patients with active, previously untreated disease for more than 4 months (VICI): a randomised, double-blind, placebo-controlled trial",

abstract = "Background:In chronic central serous chorioretinopathy (CSCR), fluid accumulates in the sub-retinal space. It is a common visually disabling condition in individuals of working age. There is no definitive treatment. Previous research suggests the mineralocorticoid receptor antagonist, eplerenone, is effective for treating CSCR but it is not licensed for this indication. We evaluated whether eplerenone is superior to placebo for treating chronic CSCR.Methods:We conducted a placebo-controlled parallel-group randomised trial in 22 United Kingdom hospitals. Participants were aged ≥18 and ≤60 years with treatment na{\"i}ve CSCR for ≥4 months. Randomisation stratified by best-corrected visual acuity (BCVA) and hospital was performed online, with participants randomised to receive oral eplerenone (25 mg/day for one week, increasing to 50 mg/day for up to 12 months) plus usual care or placebo plus usual care. Participants, care teams, outcome assessors, pharmacists and the trial management group were masked. The primary outcome was BCVA at 12 months. All outcomes apart from safety were analysed on a modified intention-to-treat basis. The trial is registered: ISRCTN92746680.Findings:Between 11/01/2017 and 22/02/2018, 57 participants were randomised to eplerenone and 57 to placebo; 57 and 54 participants respectively were included in the final analysis. Modelled mean BCVA at 12 months in the placebo and eplerenone groups were 79.5 (SD 4.5) and 80.4 (SD 4.6) letters, with an adjusted estimated difference (eplerenone minus placebo) of 1.73 letters (95% confidence interval -1.12 to 4.57, p=0·24) at 12 months. Hyperkalaemia occurred in eight participants in each group (14%). No serious adverse events occurred in the eplerenone group; three unrelated serious adverse events occurred in the placebo group.Interpretation:Eplerenone was not superior to placebo in improving BCVA in people with chronic CSCR during 12 months follow-up.FundingEfficacy and Mechanism Evaluation Programme, National Institute for Health Research and Social Care.",

author = "Andrew Lotery and Sobha Sivaprasad and O'Connell, {Abby J} and Harris, {Rosie A} and Culliford, {Lucy A} and Ellis, {Lucy A} and Angela Cree and Savita Madhusudan and Francine Behar-Cohen and Usha Chakravarthy and Tunde Peto and Rogers, {Chris A} and Reeves, {Barnaby C}",

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language = "English",

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pages = "294--303",

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Lotery, A, Sivaprasad, S, O'Connell, AJ, Harris, RA , Culliford, LA, Ellis, LA, Cree, A, Madhusudan, S, Behar-Cohen, F, Chakravarthy, U, Peto, T, Rogers, CA & Reeves, BC 2020, 'Eplerenone for chronic central serous chorioretinopathy in patients with active, previously untreated disease for more than 4 months (VICI): a randomised, double-blind, placebo-controlled trial', Lancet, vol. 395, no. 10220, pp. 294-303. https://doi.org/10.1016/S0140-6736(19)32981-2

Eplerenone for chronic central serous chorioretinopathy in patients with active, previously untreated disease for more than 4 months (VICI): a randomised, double-blind, placebo-controlled trial. / Lotery, Andrew; Sivaprasad, Sobha; O'Connell, Abby J et al.
In: Lancet, Vol. 395, No. 10220, 25.01.2020, p. 294-303.

Research output: Contribution to journal › Article (Academic Journal) › peer-review

TY - JOUR

T1 - Eplerenone for chronic central serous chorioretinopathy in patients with active, previously untreated disease for more than 4 months (VICI)

T2 - a randomised, double-blind, placebo-controlled trial

AU - Lotery, Andrew

AU - Sivaprasad, Sobha

AU - O'Connell, Abby J

AU - Harris, Rosie A

AU - Culliford, Lucy A

AU - Ellis, Lucy A

AU - Cree, Angela

AU - Madhusudan, Savita

AU - Behar-Cohen, Francine

AU - Chakravarthy, Usha

AU - Peto, Tunde

AU - Rogers, Chris A

AU - Reeves, Barnaby C

PY - 2020/1/25

Y1 - 2020/1/25

N2 - Background:In chronic central serous chorioretinopathy (CSCR), fluid accumulates in the sub-retinal space. It is a common visually disabling condition in individuals of working age. There is no definitive treatment. Previous research suggests the mineralocorticoid receptor antagonist, eplerenone, is effective for treating CSCR but it is not licensed for this indication. We evaluated whether eplerenone is superior to placebo for treating chronic CSCR.Methods:We conducted a placebo-controlled parallel-group randomised trial in 22 United Kingdom hospitals. Participants were aged ≥18 and ≤60 years with treatment naïve CSCR for ≥4 months. Randomisation stratified by best-corrected visual acuity (BCVA) and hospital was performed online, with participants randomised to receive oral eplerenone (25 mg/day for one week, increasing to 50 mg/day for up to 12 months) plus usual care or placebo plus usual care. Participants, care teams, outcome assessors, pharmacists and the trial management group were masked. The primary outcome was BCVA at 12 months. All outcomes apart from safety were analysed on a modified intention-to-treat basis. The trial is registered: ISRCTN92746680.Findings:Between 11/01/2017 and 22/02/2018, 57 participants were randomised to eplerenone and 57 to placebo; 57 and 54 participants respectively were included in the final analysis. Modelled mean BCVA at 12 months in the placebo and eplerenone groups were 79.5 (SD 4.5) and 80.4 (SD 4.6) letters, with an adjusted estimated difference (eplerenone minus placebo) of 1.73 letters (95% confidence interval -1.12 to 4.57, p=0·24) at 12 months. Hyperkalaemia occurred in eight participants in each group (14%). No serious adverse events occurred in the eplerenone group; three unrelated serious adverse events occurred in the placebo group.Interpretation:Eplerenone was not superior to placebo in improving BCVA in people with chronic CSCR during 12 months follow-up.FundingEfficacy and Mechanism Evaluation Programme, National Institute for Health Research and Social Care.

AB - Background:In chronic central serous chorioretinopathy (CSCR), fluid accumulates in the sub-retinal space. It is a common visually disabling condition in individuals of working age. There is no definitive treatment. Previous research suggests the mineralocorticoid receptor antagonist, eplerenone, is effective for treating CSCR but it is not licensed for this indication. We evaluated whether eplerenone is superior to placebo for treating chronic CSCR.Methods:We conducted a placebo-controlled parallel-group randomised trial in 22 United Kingdom hospitals. Participants were aged ≥18 and ≤60 years with treatment naïve CSCR for ≥4 months. Randomisation stratified by best-corrected visual acuity (BCVA) and hospital was performed online, with participants randomised to receive oral eplerenone (25 mg/day for one week, increasing to 50 mg/day for up to 12 months) plus usual care or placebo plus usual care. Participants, care teams, outcome assessors, pharmacists and the trial management group were masked. The primary outcome was BCVA at 12 months. All outcomes apart from safety were analysed on a modified intention-to-treat basis. The trial is registered: ISRCTN92746680.Findings:Between 11/01/2017 and 22/02/2018, 57 participants were randomised to eplerenone and 57 to placebo; 57 and 54 participants respectively were included in the final analysis. Modelled mean BCVA at 12 months in the placebo and eplerenone groups were 79.5 (SD 4.5) and 80.4 (SD 4.6) letters, with an adjusted estimated difference (eplerenone minus placebo) of 1.73 letters (95% confidence interval -1.12 to 4.57, p=0·24) at 12 months. Hyperkalaemia occurred in eight participants in each group (14%). No serious adverse events occurred in the eplerenone group; three unrelated serious adverse events occurred in the placebo group.Interpretation:Eplerenone was not superior to placebo in improving BCVA in people with chronic CSCR during 12 months follow-up.FundingEfficacy and Mechanism Evaluation Programme, National Institute for Health Research and Social Care.

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U2 - 10.1016/S0140-6736(19)32981-2

DO - 10.1016/S0140-6736(19)32981-2

M3 - Article (Academic Journal)

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SN - 0140-6736

VL - 395

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EP - 303

JO - Lancet

JF - Lancet

IS - 10220

ER -

Eplerenone for chronic central serous chorioretinopathy in patients with active, previously untreated disease for more than 4 months (VICI): a randomised, double-blind, placebo-controlled trial

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Eplerenone for chronic central serous chorioretinopathy in patients with active, previously untreated disease for more than 4 months (VICI): a randomised, double-blind, placebo-controlled trial

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