Intravitreal aflibercept for management of choroidal neovascularization secondary to angioid streaks

2020 ◽  
pp. 112067212092830
Author(s):  
Maurizio Battaglia Parodi ◽  
Maria Vittoria Cicinelli ◽  
Alessandro Marchese ◽  
Chiara Giuffrè ◽  
Francesco Viola ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Adverse Events ◽  
Choroidal Neovascularization ◽  
Central Macular Thickness ◽  
Angioid Streaks ◽  
Serious Adverse Events ◽  
Corrected Visual Acuity ◽  
Intravitreal Aflibercept ◽  
Best Corrected Visual Acuity

Purpose To investigate the effect and the safety of intravitreal aflibercept in patients affected by choroidal neovascularization secondary to angioid streaks with a long-term follow-up. Methods Multicentre, open-label, phase IIb study (EYLEA-STRIE, EudraCT Number 2014-000986-30) involving four Italian centres (IRCCS Ospedale San Raffaele (Milano), Fondazione G.B. Bietti (Roma), Policlinico (Milano), Ospedale Luigi Sacco (Milano)). Patients with active choroidal neovascularization secondary to angioid streaks with foveal involvement were prospectively enrolled and followed for 18 months. All the patients received intravitreal 2 mg/0.05 mL aflibercept at the time of enrolment, followed by a pro-re-nata regimen for 48 weeks. Best-corrected visual acuity and central macular thickness were measured monthly. Adverse events were monitored at each visit. Results Twenty-three eyes of 20 patients were analysed. Mean number of injections per patient was 4.30 ± 1.2. At week 48, the best-corrected visual acuity was 0.42 ± 0.40 LogMAR (p = 0.6 from baseline) and 18 eyes (81.8%) featured stability within 15 letters. The central macular thickness significantly reduced (p = 0.03). Eleven ocular non-serious adverse events and two serious adverse events were observed (one case of endophthalmitis and one case of acute gastritis were reported). Conclusion Intravitreal aflibercept represents a valid option for the management of choroidal neovascularization complicating angioid streaks. Further studies with longer follow-up and different therapeutic regimens are warranted to ascertain the best control of the disease.

Switching from ranibizumab to aflibercept in choroidal neovascularization secondary to angioid streaks

2019 ◽  
Vol 30 (3) ◽  
pp. 550-556 ◽  
Author(s):  
Rim Sekfali ◽  
Gérard Mimoun ◽  
Salomon Yves Cohen ◽  
Giuseppe Querques ◽  
Francesco Bandello ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Choroidal Neovascularization ◽  
Subretinal Fluid ◽  
Central Macular Thickness ◽  
Angioid Streaks ◽  
Intravitreal Ranibizumab ◽  
Corrected Visual Acuity ◽  
Intravitreal Aflibercept ◽  
Secondary Endpoints ◽  
Best Corrected Visual Acuity

Purpose: To evaluate the efficacy of switching from intravitreal ranibizumab to intravitreal aflibercept in choroidal neovascularization secondary to angioid streaks. Design: Multicenter retrospective interventional case series. Methods: Patients previously treated with intravitreal ranibizumab with at least 12-month follow-up (M12) after switching (M0) to intravitreal aflibercept. Switch to intravitreal aflibercept was decided in cases of refractory or recurrent choroidal neovascularization. Primary endpoint: Change of best-corrected visual acuity using the Early Treatment Diabetic Retinopathy Study letters. Secondary endpoints: Mean change of central macular thickness, absence of intraretinal/subretinal fluid on spectral domain optical coherence tomography and the percentage of eyes with absence of leakage on fluorescein angiography. Results: Fourteen eyes of 13 patients were included. Mean best-corrected visual acuity was 65.0 ± 21.03 letters at M0 and 63.5 ± 17.30 letters at M12 (p = 0.5). Secondary endpoints: Mean central macular thickness was 344 ± 194.65 µm at M0 and 268 ± 79.97 µm at M12 (p = 0.008). Absence of intraretinal/subretinal fluid was observed in 71%. Fluorescein angiography (nine eyes) showed absence of leakage in 77% (seven eyes). Conclusion: Switching from intravitreal ranibizumab to intravitreal aflibercept represents a therapeutic option in patients with refractory or recurrent choroidal neovascularization secondary to angioid streaks.

Comparison of aflibercept and ranibizumab in diabetic macular edema associated with subretinal detachment

2019 ◽  
Vol 30 (2) ◽  
pp. 363-369 ◽  
Author(s):  
Abdullah Ozkaya ◽  
Gokhan Demir ◽  
Asli Kirmaci
Keyword(s):  
Visual Acuity ◽  
Retinal Detachment ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Secondary Outcome ◽  
Intravitreal Ranibizumab ◽  
Corrected Visual Acuity ◽  
Intravitreal Aflibercept ◽  
Best Corrected Visual Acuity

Purpose: To compare the efficacy of ranibizumab and aflibercept in the treatment of diabetic macular edema associated with subfoveal retinal detachment. Methods: This is a retrospective, comparative study. The treatment-naïve diabetic macular edema patients who had diabetic macular edema associated with subfoveal retinal detachment and underwent intravitreal aflibercept or intravitreal ranibizumab treatment were included. The patients were treated on a pro re nata treatment regimen after a loading dose of 3-monthly injections and the follow-up time was 12 months. The primary outcome measure of this study was the presence of subfoveal retinal detachment after treatment at different time points. The secondary outcome measures were the change in best corrected visual acuity and central retinal thickness. Results: A total of 46 eyes of 46 patients were included. The aflibercept group consisted of 20 and the ranibizumab group consisted of 26 eyes. During the follow-up period of 12 months, subfoveal retinal detachment was completely resolved in 75% versus 57.7% of the eyes at month 3 (p = 0.2), 90% versus 76.9% at month 6 (p = 0.2), 90% versus 65.4% at month 9 (p = 0.05), and 100% versus 80.8% at month 12 (p = 0.03) in the intravitreal aflibercept versus intravitreal ranibizumab groups. The change in best corrected visual acuity was not statistically different between the groups at months 3, 6, 9, and 12, respectively (p > 0.05 for all). Conclusion: Both intravitreal aflibercept and intravitreal ranibizumab were effective in regards to anatomical and functional outcomes of diabetic macular edema patients associated with subfoveal retinal detachment. Interestingly, intravitreal aflibercept seemed more effective than intravitreal ranibizumab in the resolution of subfoveal retinal detachment at month 12.

scholarly journals Treatment of Optic Canal Decompression Combined with Umbilical Cord Mesenchymal Stem (Stromal) Cells for Indirect Traumatic Optic Neuropathy: A Phase 1 Clinical Trial

2020 ◽  
Vol 64 (3) ◽  
pp. 398-404
Author(s):  
Jia Li ◽  
Xu Bai ◽  
Xiaoyue Guan ◽  
Hongfeng Yuan ◽  
Xiang Xu
Keyword(s):  
Visual Acuity ◽  
Adverse Events ◽  
Phase 1 ◽  
Optic Canal ◽  
Traumatic Optic Neuropathy ◽  
Corrected Visual Acuity ◽  
Group 2 ◽  
Best Corrected Visual Acuity ◽  
Group 1

<b><i>Purpose:</i></b> This study was aimed to investigate the safety and feasibility of umbilical cord-derived mesenchymal stem cell (MSC) transplantation in patients with traumatic optic neuropathy (TON). <b><i>Methods:</i></b> This is a single-center, prospective, open-labeled phase 1 study that enrolled 20 patients with TON. Patients consecutively underwent either optic canal decompression combined with MSC local implantation treatment (group 1) or only optic canal decompression (group 2). Patients were evaluated on the first day, seventh day, first month, third month, and sixth month postoperatively. Adverse events, such as fever, urticarial lesions, nasal infection, and death, were recorded at each visit. The primary outcome was changes in best-corrected visual acuity. The secondary outcomes were changes in color vision, relative afferent pupillary defect, and flash visual evoked potential. <b><i>Results:</i></b> All 20 patients completed the 6-month follow-up. None of them had any systemic or ocular complications. The change in best-corrected visual acuity at follow-up was not significantly different between group 1 and group 2 (<i>p</i> &#x3e; 0.05); however, group 1 showed better visual outcome than group 2. Both groups showed significant improvements in vision compared with the baseline (<i>p</i> &#x3c; 0.05); however, there were no statistically significant differences between the groups (<i>p</i> &#x3e; 0.05). In addition, no adverse events related to local transplantation were observed in the patients. <b><i>Conclusions:</i></b> A single, local MSC transplantation in the optic nerve is safe for patients with TON.

scholarly journals Triamcinolone and Bevacizumab as Adjunctive Therapies to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

2012 ◽  
Vol 2012 ◽  
pp. 1-10 ◽  
Author(s):  
F. Lopez-Lopez ◽  
F. Gomez-Ulla ◽  
M. J. Rodriguez-Cid ◽  
L. Arias
Keyword(s):  
Visual Acuity ◽  
Diabetic Retinopathy ◽  
Contrast Sensitivity ◽  
Proliferative Diabetic Retinopathy ◽  
Panretinal Photocoagulation ◽  
Central Macular Thickness ◽  
Intravitreal Triamcinolone ◽  
Corrected Visual Acuity ◽  
Best Corrected Visual Acuity

Purpose. To evaluate efficacy of intravitreal triamcinolone (IVT) and bevacizumab (IVB) as adjunctive treatments to panretinal photocoagulation (PRP) in proliferative diabetic retinopathy (PDR). Methods. In 60 eyes of 45 patients with PDR, PRP (PRP group), PRP with IVT (IVT group), or PRP with IVB (IVB group) was performed. Regression of new vessels (NV), changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), and contrast sensitivity at 1,2, and 6 months were evaluated. Results. Initial mean numbers of active NV and BCVA were 3.45 and 67.35 in the PRP group, 4.35 and 76.65 in the IVT group, and 4.79 and 75.53 in the IVB group. At the 6-month follow-up, numbers of active NV were 2.5 (P=0.064), 1.11 (P=0.000), and 1.11 (P=0.002), and there was a mean loss of 2,6 (P=0.055), 3.9 (P=0.011), and 0.9 letters (P=0.628) in the PRP, IVT, and IVB groups, respectively. Changes in CMT in the PRP and IVT groups were not significant, but significantly increased in the IVB group (P=0.032). Contrast sensitivity remained stable in PRP and IVB groups and slightly decreased in IVT group. Conclusions. Adjunctive use of both triamcinolone and bevacizumab with PRP lead to a greater reduction of active NV than PRP alone in PDR, although no differences were seen between the two of them.

scholarly journals Avaliação dos Resultados do Tratamento Antiangiogénico na Neovascularização Coroideia Associada à Miopia Patológica

2014 ◽  
Vol 27 (1) ◽  
pp. 49 ◽  
Author(s):  
Beatriz Carvalho ◽  
Paulo Freitas-Costa ◽  
João Pinheiro-Costa ◽  
Manuel Falcão ◽  
Ângela Carneiro ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Choroidal Neovascularization ◽  
Vision Loss ◽  
Long Term Results ◽  
Myopic Choroidal Neovascularization ◽  
Corrected Visual Acuity ◽  
Foveal Center ◽  
Best Corrected Visual Acuity

<strong>Introduction:</strong> Choroidal neovascularization secondary to pathological myopia is one of the leading causes of irreversible central vision loss in younger patients. The purposes of our study is to evaluate the long-term results of antiangiogenic treatment, with ranibizumab and/or bevacizumab, in myopic choroidal neovascularization and define the predictive factors for visual and anatomic outcomes.<br /><strong>Material and Methods:</strong> In this study were included 84 eyes from 81 patients with myopic choroidal neovascularization. Eighty-four (100%) eyes accomplish 12 months of follow-up, 67 (79.8%) 24 months, 54 (64.3%) 36 months, 29 (34.5%) 48 months, and 15 (16.7%) 60 months. We retrieved data related to best corrected visual acuity measured with ETDRS chart, foveal center thickness on optical coherence tomography and fluorescein angiographic findings, before and after treatment.<br />Results: The best corrected visual acuity and foveal center thickness improvements were statistically significant for all follow-up times (p &lt; 0.05). Mean baseline best corrected visual acuity was 43.7 ± 20.1 letters and mean baseline foveal center thickness was 304.8 ± 127.9μm. Mean best corrected visual acuity was 55.6 ± 18.5, 52.1 ± 22.3, 52.1 ± 22.6, 50.3 ± 23.8 and 47.8 ± 24.5 for 12, 24, 36, 48 and 60 months of treatment, respectively. Mean foveal center thickness was 209.7 ± 86.2, 190.6 ± 76.1, 174.7 ± 60.6, 189.8 ± 96.7 and 159.4 ± 73.3 for the same follow-up times. Baseline best corrected visual acuity was the only predictive factor for better visual outcome (p &lt; 0.001).<br /><strong>Discussion/Conclusion:</strong> Intravitreal anti-VEGF injections in patients with myopic choroidal neovascularization yielded a significant and sustained functional and anatomic improvement. Randomized long-term clinical trials are needed to determine the sustained efficacy of these drugs.

scholarly journals Αγγειοειδείς ταινίες

2006 ◽  
Author(s):  
Ηλίας Γεωργαλάς
Keyword(s):  
Visual Acuity ◽  
Photodynamic Therapy ◽  
Laser Photocoagulation ◽  
Age Related Macular Degeneration ◽  
Fundus Photography ◽  
Angioid Streaks ◽  
Corrected Visual Acuity ◽  
Best Corrected Visual Acuity ◽  
Group 1

Angioid streaks are irregular crack like dehiscences in Bruch's membrane that invariably radiate outward from the peripapillary area in all directions9. They are associated with a wide variety of systemic diseases, such as pseudoxanthoma elasticum, Ehler-Danlos syndrome, Paget's disease and sickle-cell hemoglobinopathies9.The prognosis in patients with angioid streaks is guarded because visual impairment occurs in 70% to 86% due to the occurrence of macular choroidal neovascularization (CNV)9,15,51. The natural history of such lesions is poor, with most resulting in fovea involvement and central vision loss9,187. Laser photocoagulation treatment of CNV may be beneficial in selected cases169,171,189,191. However, the recurrence rate is higher than with CNV associated with other macular disorders168,170 and the final results reported in the literature as being rather disappointing9. Recently, limited macular translocation176,177, as well as photodynamic therapy with verteporfin (PDT)151,152,154,155,157,182 were searched as alternative treatment modalities for subfoveal CNV due to angioid streaks in small series of patients with controversial results.The purpose of this study is to evaluate the effectiveness of conventional PDT with verteporfin in a large series of patients with subfoveal or juxtafoveal CNV due to angioid streaks and to compare it to the effectiveness of early retreatment PDT (8 weeks following initial therapy) in patients who experienced disease progression.MATERIALS AND METHODSA prospective analysis of 36 eyes of 33 consecutive patients with subfoveal or juxtafoveal CNV secondary to angioid streaks that were treated with PDT from January 2001 through January 2005 and completed at least 18 months of the follow-up time, was conducted. The greatest linear dimension of the entire lesion had to be 6000 pm or less. Eyes with best corrected visual acuity of less than 20/400 were not treated. None of the eyes had been previously treated by conventional laser photocoagulation for the macular CNV.Prior to the treatment, each patient had undergone a complete ocular examination including contact lens fundus biomicroscopy, color or red-free fundus photography, and digital fluorescein angiography (FA) using the Topcon Imagenet 2000 Digital Imaging System with TRC-50IA fundus camera (Topcon Corporation, Paramus, New Jersey, USA). Fluorescein angiograms were evaluated for lesion size and leakage of the neovascular membrane. Best-corrected visual acuity was determined in all patients using standard Snellen charts.Patients were divided in 2 groups. In group 1, retreatments were performed according to the standard protocol followed in the Treatment of Age-Related Macular Degeneration with Photodynamic Therapy Investigation (TAP) every 12 weeks107, 146. During this time, 17 eyes of 15 patients were included in the study in Group 1. In Group 2, 19 eyes of 17 patients received early retreatments (8 weeks after the previous PDT) when indicated according to the criteria of the TAP study for conventional 3-month retreatment.The follow-up time of the patients ranged from 18 to 66 months (mean 37.6 months). The re-examinations followed the same procedure as the first examination. Informed consent for examination and treatment was obtained from each patient after a full explanation of the procedure.Numerical data in the text and the tables are presented as mean (±SD). Improvement or decline of visual acuity was defined as a change of at least two lines.

scholarly journals The efficacy of intravitreal conbercept for chronic central serous chorioretinopathy: a retrospective clinical study

2019 ◽  
Author(s):  
Jianbo Mao ◽  
Caiyun Zhang ◽  
Chenyi Liu ◽  
Lijun Shen ◽  
Jimeng Lao ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Clinical Study ◽  
Central Serous Chorioretinopathy ◽  
Central Macular Thickness ◽  
Chronic Central Serous Chorioretinopathy ◽  
Corrected Visual Acuity ◽  
Retrospective Clinical Study ◽  
The Difference ◽  
Best Corrected Visual Acuity

Abstract Background: To evaluate the efficacy and safety of conbercept for patients with chronic central serous chorioretinopathy (CSC). Methods: A retrospective clinical study. This study included twenty-seven patients (32 eyes) who were diagnosed with chronic CSC in our hospital from November 2015 to March 2018. All the patients received intravitreal conbercept with one intravitreal injection and pro re nata (PRN). Follow-up observations occurred at 1 week and 1, 2, 3, and 6 months after initial injection. Observed indicators included best-corrected visual acuity (BCVA), central macular thickness (CMT) and presence of subretinal fluid (SRF). Results: During the 6-month follow-up, the mean number of injections required and performed was 1.50±0.67. The BCVA at the first visit, 1-week, 1-, 2-, 3- and 6-month follow-ups after the first injection was 0.44±0.26, 0.39±0.29, 0.38±0.29, 0.33±0.29, 0.31±0.30, and 0.31±0.29, respectively. The difference between the BCVA at each follow-up and the first visit was statistically significant (F=9.717, P<0.05). CMT at the first visit, 1-week, 1-, 2-, 3- and 6- month after first injection was 323.25±158.49μm, 263.78±122.52μm, 222.34±92.46μm, 195.63±69.18μm, 189.25±68.71μm, and 200.47±86.30μm, respectively. The difference between the CMT at each follow-up and the first visit was also statistically significant (F=17.072, P<0.05). Full resolution of fluid was achieved in 7 (21.9%) eyes at 1 month, 14 (43.8%) eyes at 2 months, 19 (59.4%) eyes at 3 months and 23 (71.9%) eyes at 6 months after the initial treatment of anti-VEGF injection. No severe adverse event was noted relevant to the therapy. Conclusion: Intravitreal injection of conbercept can effectively reduce the CMT and improve the BCVA in chronic CSC in a short term of 6 months. Keywords: Chronic central serous chorioretinopathy, Conbercept, Best-corrected visual acuity, Central macular thickness.

Optical coherence tomography angiography in myopic choroidal neovascularization after intravitreal ranibizumab

2018 ◽  
Vol 29 (2) ◽  
pp. 239-243
Author(s):  
Gilda Cennamo ◽  
Francesca Amoroso ◽  
Stefano Schiemer ◽  
Nunzio Velotti ◽  
Mariacristina Alfieri ◽  
...  
Keyword(s):  
Optical Coherence Tomography ◽  
Visual Acuity ◽  
Choroidal Neovascularization ◽  
Optical Coherence Tomography Angiography ◽  
Pathologic Myopia ◽  
Optical Coherence ◽  
Intravitreal Ranibizumab ◽  
Corrected Visual Acuity ◽  
Best Corrected Visual Acuity

Purpose: To describe the optical coherence tomography angiography characteristics of myopic patients with choroidal neovascularization secondary to pathologic myopia during ranibizumab therapy. Methods: Nineteen patients were enrolled in this prospective study (13 females, 6 males, mean age 55.25 ± 9.63 years) for a total of 20 eyes examined (14 right eyes, 6 left eyes). Images were analyzed independently by two examiners. Results: Mean follow-up was 5.75 ± 1.88 months, with a mean intravitreal injections of 1.90 ± 0.44. Mean best-corrected visual acuity at baseline was 0.39 ± 0.18 logMAR versus 0.26 ± 0.16 logMAR 6 months after treatment. The neovascular area (Z = –2.091, p = 0.037) was significantly reduced after treatment, whereas vessel density was not (Z = –1.848, p = 0.065). Moreover, the best-corrected visual acuity was increased (Z = –3.055, p = 0.002). Neovascular area was significantly correlated with best-corrected visual acuity, at both baseline and follow-up (p < 0.05). Conclusion: Our data suggest that optical coherence tomography angiography is a reproducible non-invasive examination with which to monitor changes in the neovascular area in patients with pathologic myopia treated with ranibizumab.

scholarly journals Safety of various parameter sets with navigated microsecond pulsing laser in central serous chorioretinopathy

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Jay Chhablani ◽  
Gagan Kalra ◽  
Lubna Alkwatli ◽  
Bernd Fassbender ◽  
Francesca Amoroso ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Adverse Events ◽  
Central Serous Chorioretinopathy ◽  
Retinal Thickness ◽  
Subretinal Fluid ◽  
Central Retinal Thickness ◽  
Duration Of Symptoms ◽  
Corrected Visual Acuity ◽  
Best Corrected Visual Acuity

Abstract Background Subthreshold microsecond pulsing laser is an increasingly common treatment approach for central serous chorioretinopathy. However, there is no literature available on the safety of microsecond laser using different fluence settings in this disease. While many publications can be obtained from conventional microsecond pulsing lasers, few parameter sets are published with the navigated microsecond pulsing laser. Therefore, this study aims to investigate the safety of different parameter sets in subthreshold microsecond pulsing laser treatments. Methods In this retrospective chart review, consecutive patients with central serous chorioretinopathy (> 3 months duration of symptoms) treated with navigated subthreshold microsecond pulsing laser and a follow up of at least five months after microsecond laser application were included. For each patient, the treatment parameters, plan layout, and adverse events related to laser were evaluated. Secondary outcomes included best-corrected visual acuity and anatomical improvements (central retinal thickness). Results One hundred and one eyes were included in the observation and followed for a mean of 10 months (range 5–36). Although a larger range of parameter sets and fluence settings have been used, no patient demonstrated adverse events from navigated microsecond pulsing laser. While 88% of the cases demonstrated stability, 13 cases lost five or more letters due to the persistence of the subretinal fluid. In mean, a best-corrected visual acuity improvement of 0.07logMar (± 0.2) was seen (p = 0.02). In 51% of the patients, a statistically significant improvement of the central retinal thickness was noted at the last follow-up with a mean thickness reduction of 70 µm (± 143) (p < 0.01). Conclusion In conclusion, none of the used parameter sets lead to tissue damage (when using a cautious titration) and, in summary, lead to an improvement in subretinal fluid and improvement in visual acuity. However, further prospective studies are needed to correctly identify the dependency of the treatment strategy on the outcome criteria.

scholarly journals Eplerenone versus placebo for chronic central serous chorioretinopathy: the VICI RCT

2021 ◽  
Vol 8 (2) ◽  
pp. 1-82
Author(s):  
Andrew Lotery ◽  
Sobha Sivaprasad ◽  
Abby O’Connell ◽  
Rosie A Harris ◽  
Lucy Culliford ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Adverse Events ◽  
Usual Care ◽  
Central Serous Chorioretinopathy ◽  
Subretinal Fluid ◽  
Serious Adverse Events ◽  
Chronic Central Serous Chorioretinopathy ◽  
Corrected Visual Acuity ◽  
Acuity Score ◽  
Best Corrected Visual Acuity

Background In chronic central serous chorioretinopathy, fluid accumulates in the subretinal space and causes permanent vision loss in ≈ 30% of patients. There is no definitive treatment. Previous research suggests that the mineralocorticoid receptor antagonist eplerenone is effective but it is not licensed for chronic central serous chorioretinopathy. Objectives The objective was to evaluate whether or not eplerenone was safe and superior to placebo for treating chronic central serous chorioretinopathy. We also aimed to set up a biobank of DNA, serum and plasma samples from treatment-naive participants for future research. Design The trial was a parallel, randomised (1 : 1 ratio), multicentre, double-masked, placebo-controlled superiority trial comparing eplerenone plus usual care with placebo plus usual care. Participants were randomly allocated to eplerenone or placebo using a secure online system that returned a unique number corresponding to a bottle of the investigational medicinal product. Participants, clinical care teams, pharmacists, outcome assessors and the trial management group were masked. Setting The trial took place in 22 NHS hospitals in the UK. Participants Eligible participants were patients aged 18–60 years with treatment-naive chronic central serous chorioretinopathy of at least 4 months’ duration, a best corrected visual acuity score of 54–85 letters and no other conditions affecting visual acuity or contraindications to taking eplerenone or placebo. Interventions The intervention was oral eplerenone (25 mg/day for 1 week, increased to 50 mg/day for up to 12 months). Placebo was a lactose-filled capsule that appeared identical to the overencapsulated eplerenone tablets. To maintain blinding, participants in the placebo group followed the same dose escalation schedule as the eplerenone group. Usual care was included in both groups and was administered at the discretion of clinicians. Main outcome measures The primary outcome was best corrected visual acuity score at 12 months. Secondary outcomes were low-luminance visual acuity, central subfield retinal thickness, change in subretinal fluid thickness, systemic and ocular adverse events, macular atrophy of the retinal pigment epithelium, subfoveal choroidal thickness, choroidal permeability, resolution of subretinal fluid, time to recurrence of subretinal fluid, fundus fluorescein angiography phenotype, incidence of chronic central serous chorioretinopathy in the fellow eye, and patient-reported visual function. Results Between 11 January 2017 and 22 February 2018, 57 participants were randomised to eplerenone and 57 to placebo; 57 and 54 participants, respectively, were included in the analysis of the primary outcome. The modelled mean best corrected visual acuity score at 12 months in the eplerenone and placebo groups was 80.4 letters (standard deviation 4.6 letters) and 79.5 letters (standard deviation 4.5 letters), with an estimated difference between groups of 1.73 letters (95% confidence interval –1.12 to 4.57 letters; p = 0.24). 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. Limitations Limitations included the inability to prevent co-treatments and discontinuation of the investigational medicinal product in the event of resolution or hyperkalaemia. Conclusions Eplerenone was safe but not superior to placebo in improving best corrected visual acuity in people with chronic central serous chorioretinopathy during 12 months of follow-up. In future work, ophthalmologists should investigate alternative treatments for this condition, which remains complicated to treat. Trial registration Current Controlled Trials ISRCTN92746680. Funding This project was funded by the Efficacy and Mechanism Evaluation (EME) Programme, a MRC and National Institute for Health Research (NIHR) partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 8, No. 2. See the NIHR Journals Library website for further project information.

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