title: A 50% vs 30% dose of verteporfin (photodynamic therapy) for acute central serous chorioretinopathy: one-year results of a randomized clinical trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  A 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.
  
  
  METHODS
  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).
  
  
  METHODS
  The 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.
  
  
  RESULTS
  The 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
  A 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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01574430.
authors.affiliation: Department of Ophthalmology, Peking University People's Hospital, Beijing, People's Republic of China2Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroidal Disease, Beijing, People's Republic of China3Key Laboratory of Vision Loss and R.
authors.forename: Mingwei
authors.initials: M
authors.lastname: Zhao
authors.affiliation: Department of Ophthalmology, Capital Medical University Beijing Tong Ren Hospital, Beijing, People's Republic of China.
authors.forename: Feng
authors.initials: F
authors.lastname: Zhang
authors.affiliation: Department of Ophthalmology, Beijing Union Medical College Hospital, Beijing, People's Republic of China.
authors.forename: Youxin
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Department of Ophthalmology, Beijing Hospital of the Ministry of Health, Beijing, People's Republic of China.
authors.forename: Hong
authors.initials: H
authors.lastname: Dai
authors.affiliation: Department of Ophthalmology, Peking University People's Hospital, Beijing, People's Republic of China2Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroidal Disease, Beijing, People's Republic of China3Key Laboratory of Vision Loss and R.
authors.forename: Jinfeng
authors.initials: J
authors.lastname: Qu
authors.affiliation: Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, People's Republic of China.
authors.forename: Chongya
authors.initials: C
authors.lastname: Dong
authors.affiliation: Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, People's Republic of China.
authors.forename: Xiaoping
authors.initials: X
authors.lastname: Kang
authors.affiliation: Department of Ophthalmology, Peking University Third Hospital, Beijing, People's Republic of China.
authors.forename: Yuling
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Department of Ophthalmology, Peking University First Hospital, Beijing, People's Republic of China.
authors.forename: Liu
authors.initials: L
authors.lastname: Yang
authors.affiliation: Beijing Institute of Ophthalmology, Capital Medical University Beijing Tong Ren Hospital, Beijing, People's Republic of China.
authors.forename: Yibin
authors.initials: Y
authors.lastname: Li
authors.affiliation: Department of Ophthalmology, Peking University People's Hospital, Beijing, People's Republic of China2Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroidal Disease, Beijing, People's Republic of China3Key Laboratory of Vision Loss and R.
authors.forename: Peng
authors.initials: P
authors.lastname: Zhou
authors.affiliation: Department of Ophthalmology, Peking University People's Hospital, Beijing, People's Republic of China2Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroidal Disease, Beijing, People's Republic of China3Key Laboratory of Vision Loss and R.
authors.forename: Chung-Ting
authors.initials: CT
authors.lastname: Pan
authors.affiliation: Department of Ophthalmology, Peking University People's Hospital, Beijing, People's Republic of China2Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroidal Disease, Beijing, People's Republic of China3Key Laboratory of Vision Loss and R.
authors.forename: Lijuan
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Department of Ophthalmology, Peking University People's Hospital, Beijing, People's Republic of China2Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroidal Disease, Beijing, People's Republic of China3Key Laboratory of Vision Loss and R.
authors.forename: Peipei
authors.initials: P
authors.lastname: Liu
authors.affiliation: Department of Ophthalmology, Capital Medical University Beijing Tong Ren Hospital, Beijing, People's Republic of China.
authors.forename: Haiying
authors.initials: H
authors.lastname: Zhou
authors.affiliation: Department of Ophthalmology, Capital Medical University Beijing Tong Ren Hospital, Beijing, People's Republic of China.
authors.forename: Xuan
authors.initials: X
authors.lastname: Jiao
authors.affiliation: Department of Ophthalmology, Capital Medical University Beijing Tong Ren Hospital, Beijing, People's Republic of China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Xiong
authors.affiliation: Department of Ophthalmology, Beijing Union Medical College Hospital, Beijing, People's Republic of China.
authors.forename: Rong
authors.initials: R
authors.lastname: Tian
authors.affiliation: Department of Ophthalmology, Beijing Hospital of the Ministry of Health, Beijing, People's Republic of China.
authors.forename: Yingyi
authors.initials: Y
authors.lastname: Lu
authors.affiliation: Department of Ophthalmology, Beijing Hospital of the Ministry of Health, Beijing, People's Republic of China.
authors.forename: Xiaobing
authors.initials: X
authors.lastname: Yu
authors.affiliation: Department of Ophthalmology, Peking University People's Hospital, Beijing, People's Republic of China2Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroidal Disease, Beijing, People's Republic of China3Key Laboratory of Vision Loss and R.
authors.forename: Xiaoxin
authors.initials: X
authors.lastname: Li
mesh_terms: D000208:Acute Disease; D000328:Adult; D002199:Capillary Permeability; D056833:Central Serous Chorioretinopathy / Q000188:drug therapy* / Q000378:metabolism; D004396:Coloring Agents; D004311:Double-Blind Method; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D007208:Indocyanine Green; D008297:Male; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000008:administration & dosage* / Q000009:adverse effects; D011166:Porphyrins / Q000008:administration & dosage* / Q000009:adverse effects; D058471:Subretinal Fluid / Q000378:metabolism; D041623:Tomography, Optical Coherence; D000077362:Verteporfin
chemical_list: D004396:Coloring Agents; D017319:Photosensitizing Agents; D011166:Porphyrins; D000077362:Verteporfin; D007208:Indocyanine Green