One-year results of photodynamic therapy with chlorin e6-polyvinylpyrrolidone complex in patients with chronic central serous chorioretinopathy (pilot study)

Abstract

Purpose To investigate efficacy and safety of photodynamic therapy (PDT) with chlorin e6-polyvinylpyrrolidone (Ce6-PVP) complex in patients with chronic central serous chorioretinopathy (CSC).

Methods In this prospective, interventional, single-centre clinical pilot study included 28 patients (28 eyes) with chronic CSC. Patients received an intravenous infusion of 3 mg/m2 Ce6-PVP complex (Photolon, Belmedpreparaty pharmaceutical company, Minsk, Belarus) delivered over a period of 10 min. Exactly 15 min after the start of this infusion, a Ocular Mainster (Standard) Focal/Grid contact lens (Ocular Instruments, Bellevue, Washington, USA) was positioned on the eye, the treatment spot was centered using predefined criteria for fluorescein angiography, and PDT was applied using standard parameters (fluency, 50 J/cm2; wavelength, 662 nm; and treatment duration, 83 seconds). The primary objective was decimal best corrected visual acuity (BCVA) at Month 12. The secondary objectives were central retinal thickness (CRT) in fovea area, complete subretinal fluid (SRF) resolution, number of treatment and safety at Month 12.

Results Mean decimal BCVA showed significant increase from 0.6 ± 0.3 to 0.8 ± 0.4 (p = 0.001), mean CRT decreased significantly from 289 ± 72 to 202 ± 48 µm (p = 0.001), comparing baseline and Month 12. During all follow-up period mean number of PDT treatments was 1.2 ± 0.5. In 77% (20 eyes) were noted complete SRF resolution during observation period. There were no any systemic adverse events and ocular side effects.

Conclusions Our pilot study demonstrates the efficacy and safety of PDT with Ce6-PVP complex for chronic CSC during the 12-month follow-up. This finding provides key insight into developing new practice for treating chronic CSC. Futures studies in larger numbers of patients and with longer follow-up are planned to further assess the efficacy and safety of PDT with Ce6-PVP complex for chronic CSC.