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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004845
Receipt No. R000005760
Scientific Title Effect of dose schedule using Ranibizumab and Verteporfin in Japanese Polypoidal Choroidal Vasculopathy Patients (Fuji-san study)
Date of disclosure of the study information 2011/01/08
Last modified on 2015/07/08

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Basic information
Public title Effect of dose schedule using Ranibizumab and Verteporfin in Japanese Polypoidal Choroidal Vasculopathy Patients (Fuji-san study)
Acronym Dose schedule of verteporfin and ranibizumab in Japanese polypoidal choroidal vasculopathy patients

Scientific Title Effect of dose schedule using Ranibizumab and Verteporfin in Japanese Polypoidal Choroidal Vasculopathy Patients (Fuji-san study)
Scientific Title:Acronym Dose schedule of verteporfin and ranibizumab in Japanese polypoidal choroidal vasculopathy patients

Region
Japan

Condition
Condition Polypoidal Choroidal Vasculopathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the efficacy and safety of dose schedule of verteporfin in the combination treatment with ranibizumab for polypoidal choroidal vasculopathy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Best corrected visual acuity at 12 month
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Ranibizumab preceding its combined treatment with verteporfin photodynamic therapy
Interventions/Control_2 Ranibizumab combined with verteporfin photodynamic therapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1. Treatment naive, typical PCV according to the diagnostic criteria of of the PCV Study Group in Japan
2. Subfoveal hemorrhage or fluid
3. Greatest Linear Dimension (GLD) of the total lesion area <6231 micron(<12 Macular Photocoagulation Study Disc Areas) determined on ICG angiography
4. Decimal BCVA between 0.1-0.7. Male patients, and 50 yrs of age
6. Patients must give written informed consent before any assessment is performed.
Key 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
Target sample size 84

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumi Gomi
Organization Osaka University, Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 2-2, Yamadaoka, Suita, Japan
TEL 06-6879-3456
Email fgomi@ophthal.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumi Gomi
Organization Osaka University, Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 2-2, Yamadaoka, Suita, Japan
TEL 06-6879-3456
Homepage URL
Email fgomi@ophthal.med.osaka-u.ac.jp

Sponsor
Institute Fuji-san study group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 08 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25830698
Number of participants that the trial has enrolled
Results
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).
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2013 Year 08 Month 31 Day
Date of closure to data entry
2013 Year 10 Month 31 Day
Date trial data considered complete
2013 Year 12 Month 31 Day
Date analysis concluded
2014 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2011 Year 01 Month 08 Day
Last modified on
2015 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005760

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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