So Hyun Bae1, Jangwon Heo2, Cinoo Kim3, Tae Wan Kim4, Joo Young Shin5, Joo Yong Lee6, Su Jeong Song7, Tae Kwann Park8, Sang Woong Moon9, Hum Chung5. 1. Department of Ophthalmology, Hallym University College of Medicine, Kangnam Sacred Heart Hospital, Seoul, Korea. 2. Department of Ophthalmology, Seoul National University College of Medicine, Seoul, Korea; Department of Ophthalmology, Seoul National University Hospital, Seoul, Korea. Electronic address: hjw68@snu.ac.kr. 3. Seoul Plus Eye Clinic, Seoul, Korea. 4. Department of Ophthalmology, Seoul National University College of Medicine, Seoul, Korea; Department of Ophthalmology, Seoul National University, Boramae Medical Center, Seoul Metropolitan Government, Seoul, Korea. 5. Department of Ophthalmology, Seoul National University College of Medicine, Seoul, Korea; Department of Ophthalmology, Seoul National University Hospital, Seoul, Korea. 6. Department of Ophthalmology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea. 7. Department of Ophthalmology, Sungkyunkwan University College of Medicine, Kangbuk Samsung Hospital, Seoul, Korea. 8. Department of Ophthalmology, Soonchunhyang University College of Medicine, Bucheon, Korea. 9. Department of Ophthalmology, Kyunghee University College of Medicine, Seoul, Korea.
Abstract
PURPOSE: To compare the efficacy and safety between low-fluence photodynamic therapy (PDT) and the intravitreal ranibizumab in the treatment of chronic central serous chorioretinopathy (CSC). DESIGN: Prospective, randomized, single-center, parallel-arm, controlled trial. PARTICIPANTS: Thirty-four eyes of 32 patients with chronic CSC with >6 months' duration of symptoms or recurrent CSC were randomly placed into the low-fluence PDT group (n = 18) or the ranibizumab group (n = 16). INTERVENTION: The patients underwent a single session of low-fluence PDT or 3 consecutive monthly injections of ranibizumab. Rescue treatment was available from month 3 if the subretinal fluid (SRF) persisted or recurred after primary treatment; low-fluence PDT was given to the ranibizumab group and intravitreal ranibizumab to the low-fluence PDT group. MAIN OUTCOME MEASURES: The primary outcome was the proportion of eyes with complete resolution of SRF without rescue treatment. Secondary outcomes included the mean changes in logarithm of the minimum angle of resolution best-corrected visual acuity (BCVA), central retinal thickness (CRT), and angiographic findings from baseline to 12 months. RESULTS: At month 12, 16 eyes (88.9%) of the low-fluence PDT group maintained complete resolution of SRF without rescue treatment versus 2 eyes (12.5%) in the ranibizumab group (P <0.001). Two eyes (11.1%) in the low-fluence PDT group and 11 eyes (68.8%) in the ranibizumab group met the criteria for rescue treatment (P = 0.001). In the low-fluence PDT group, the mean decrease in CRT from baseline was significantly greater than that in the ranibizumab group until month 6 (P <0.05), but the differences became insignificant thereafter. The improvement in BCVA from baseline was superior in the low-fluence PDT group to that in the ranibizumab group, but the differences were not statistically significant except at month 3 (P = 0.025). On indocyanine green angiography, a significantly greater proportion of the low-fluence PDT group (16 eyes; 88.9%) showed a marked reduction in choroidal hyperpermeability after primary treatment than that of the ranibizumab group (0 eyes; P <0.001). No serious adverse events related to the drugs or procedures were observed. CONCLUSIONS: This study represents the overall superiority of low-fluence PDT compared with intravitreal ranibizumab in the treatment of chronic CSC.
RCT Entities:
PURPOSE: To compare the efficacy and safety between low-fluence photodynamic therapy (PDT) and the intravitreal ranibizumab in the treatment of chronic central serous chorioretinopathy (CSC). DESIGN: Prospective, randomized, single-center, parallel-arm, controlled trial. PARTICIPANTS: Thirty-four eyes of 32 patients with chronic CSC with >6 months' duration of symptoms or recurrent CSC were randomly placed into the low-fluence PDT group (n = 18) or the ranibizumab group (n = 16). INTERVENTION: The patients underwent a single session of low-fluence PDT or 3 consecutive monthly injections of ranibizumab. Rescue treatment was available from month 3 if the subretinal fluid (SRF) persisted or recurred after primary treatment; low-fluence PDT was given to the ranibizumab group and intravitreal ranibizumab to the low-fluence PDT group. MAIN OUTCOME MEASURES: The primary outcome was the proportion of eyes with complete resolution of SRF without rescue treatment. Secondary outcomes included the mean changes in logarithm of the minimum angle of resolution best-corrected visual acuity (BCVA), central retinal thickness (CRT), and angiographic findings from baseline to 12 months. RESULTS: At month 12, 16 eyes (88.9%) of the low-fluence PDT group maintained complete resolution of SRF without rescue treatment versus 2 eyes (12.5%) in the ranibizumab group (P <0.001). Two eyes (11.1%) in the low-fluence PDT group and 11 eyes (68.8%) in the ranibizumab group met the criteria for rescue treatment (P = 0.001). In the low-fluence PDT group, the mean decrease in CRT from baseline was significantly greater than that in the ranibizumab group until month 6 (P <0.05), but the differences became insignificant thereafter. The improvement in BCVA from baseline was superior in the low-fluence PDT group to that in the ranibizumab group, but the differences were not statistically significant except at month 3 (P = 0.025). On indocyanine green angiography, a significantly greater proportion of the low-fluence PDT group (16 eyes; 88.9%) showed a marked reduction in choroidal hyperpermeability after primary treatment than that of the ranibizumab group (0 eyes; P <0.001). No serious adverse events related to the drugs or procedures were observed. CONCLUSIONS: This study represents the overall superiority of low-fluence PDT compared with intravitreal ranibizumab in the treatment of chronic CSC.