UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004845 |
|---|---|
| Receipt number | 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 12:39:25 |
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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
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
fgomi@ophthal.med.osaka-u.ac.jp
Sponsor or person
Institute
Fuji-san study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005760
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