Effect of dose schedule using Ranibizumab and Verteporfin in Japanese Polypoidal Choroidal Vasculopathy Patients (Fuji-san study)

Not Applicable

• Conditions: Polypoidal Choroidal Vasculopathy

• Registration Number: JPRN-UMIN000004845
• Lead Sponsor: Fuji-san study group

Brief Summary

The best-corrected visual acuity increased by a mean of 8.1 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters in the initial PDT group and 8.8 ETDRS letters in the later PDT group, and there was a no significant difference (P = 0.59). The mean central retinal thickness decreased significantly in both groups but more so with combination therapy within the first 4 months; the difference was not significant at Month 12 (P = 0.30). The rate of eyes showing resolution of polypoidal lesions at 12 months was 62.1% in the initial PDT group and 54.8% in the later PDT group and again, there was no significant difference (P = 0.53). The mean number of additional IVR was 1.5 in initial PDT and 3.8 in later PDT; that of additional PDTs was 0.14 and 0.45, respectively, and they were significantly different (P < 0.001 and P = 0.013, respectively).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-08
• Study Completion: 2013-08-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

1.Histories of prior treatments for PCV 2.Hypersensitivity or allergy to fluorescein or indocyanine green (ICG), clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products, or to any of the study drugs or their components 3.Patient with history of porphyria 4.Histories of which might affect the interpretation of the results of the study, or renders the patient at high risk from treatment complications 5.Presence of RPE tears, angioid streaks, macular fibrosis, pathologic myopia (-6 diopters or more) , central serous chorioretinopathy 6.Concomitant conditions/diseases in study eyes including uncontrolled glaucoma and active ocular inflammation 7.Intraocular surgery within 2 months 8.Presence of typical type 2 CNV

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity at 12 month