A 50% vs 30% Dose of Verteporfin (Photodynamic Therapy) for Acute Central Serous Chorioretinopathy

Abstract

IMPORTANCE A randomized clinical trial is needed to evaluate what is the best photodynamic therapy (PDT) protocol to use for acute central serous chorioretinopathy.OBJECTIVE To compare the efficacy and safety of a 50% dose of verteporfin (a method of PDT) with the efficacy and safety of a 30% dose for acute central serous chorioretinopathy. DESIGN, SETTING, AND PARTICIPANTSA multicenter, noninferiority, double-masked, randomized, controlled, clinical trial in which 131 patients (131 eyes) with acute central serous chorioretinopathy for less than 6 months were recruited with a follow-up of 12 months from university-based ophthalmology practices.INTERVENTIONS Patients were randomly assigned to either a 50% dose of verteporfin (the 50%-dose PDT group) or a 30% dose (the 30%-dose PDT group). MAIN OUTCOMES AND MEASURESThe 2 primary outcome measures were the proportion of eyes with complete absorption of subretinal fluid and the proportion of eyes with complete disappearance of fluorescein leakage at 6 and 12 months. The secondary outcome measures included the subretinal fluid recurrent rate, the fluorescein leakage recurrent rate at 12 months, the mean best-corrected visual acuity, the retinal thickness of the foveal center, and the maximum retinal thickness at each scheduled visit. RESULTSThe noninferiority of the 30%-dose PDT compared with the 50%-dose PDT for the primary outcomes was not demonstrated. The optical coherence tomography-based improvement rate in the 30%-dose PDT group was less than that in the 50%-dose PDT group both at 6 months (73.8% vs 92.9%; α = 0.0125, P = .006) and at 12 months (75.4% vs 94.6%; α = 0.0125, P = .004). The fluorescein angiography-based improvement rate in the 30%-dose PDT group was less than that in the 50%-dose PDT group both at 6 months (68.9% vs 91.1%; α = 0.0125, P = .003) and at 12 months (68.9% vs 92.9%; α = 0.0125, P = .001). The subretinal fluid recurrence rate in the 30%-dose PDT group was greater than that in the 50%-dose PDT group (24.0% vs 5.7% at 12 months; P = .010, determined by use of the log-rank test). The fluorescein leakage recurrent rate in the 30%-dose PDT group was significantly higher than that in the 50%-dose PDT group (16.7% vs 3.8% at 12 months; P = .03, determined by use of the log-rank test). No ocular adverse event was encountered in the study. CONCLUSIONS AND RELEVANCEA 50% dose of verteporfin may be more effective at resolving subretinal fluid and fluorescein leakage, and with better visual outcomes, than a 30% dose for acute central serous chorioretinopathy. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01574430

Interventions for central serous chorioretinopathy: a network meta-analysis

“…Eight studies reported that outcome assessors were masked to treatment group and we judged them at low risk of detection bias (Bae 2011; Browning 1993; Chan 2008; Dang 2013; Ratanasukon 2012; Roisman 2013; Sawa 2014; Zhao 2015). Eight studies did not report any masking and the treatments were different and so we judged them at high risk of detection bias (Boscia 2008; Coskun 2014; Kim 2013; Klatt 2011; Leaver 1979; Lim 2010; Rahbani-Nobar 2011; Semeraro 2012).…”

Clinical Translation of Nanomedicine

“…144 A recent randomized clinical trial compared two doses of Visudyne in CSC. 145 This noninferiority trial attempted to demonstrate that 30% dose would be as effective as the 50% dose. However, noninferiority was not achieved and it found that the 50% dose of Visudyne is superior to 30% dose.…”

Central Serous Chorioretinopathy Treatments: A Mini Review

“…In a randomized clinical trial recruiting 131 patients, Zhao et al [53] compared the efficacy and safety of a 50% dose of PDT with the efficacy and safety of a 30% dose for acute CSC. During the 1-year follow-up, half-dose PDT was superior to 30% dose PDT in terms of resolution of subretinal fluid, fluorescein angiography leakage, recurrence of NSD and fluorescein leakage.…”

“…Many aspects remain to be determined, including the effects of PDT on chorioretinal atrophy, the role of PDT for patients showing no or minimal choroidal hyperpermeability, the action of PDT on the rate of recurrences and the cumulative effect of repeated treatments [52,53,54,55,56,57]. …”