UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017409 |
|---|---|
| Receipt number | R000020194 |
| Scientific Title | Romdomized control study of the effectiveness of pro re nata resume with intra vitreal injection of ranibizumab or aflibercept for polypoidal choroidal vasculopathy |
| Date of disclosure of the study information | 2015/05/07 |
| Last modified on | 2015/05/03 17:23:18 |
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Basic information
Public title
Romdomized control study of the effectiveness of pro re nata resume with intra vitreal injection of ranibizumab or aflibercept for polypoidal choroidal vasculopathy
Acronym
The effectiveness of PRN resume with
IVR or IVA for PCV
Scientific Title
Romdomized control study of the effectiveness of pro re nata resume with intra vitreal injection of ranibizumab or aflibercept for polypoidal choroidal vasculopathy
Scientific Title:Acronym
The effectiveness of PRN resume with
IVR or IVA for PCV
Region
| Japan |
Condition
Condition
Polypoidal choroidal vasculopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the the efficasy of pro re nata resume with ranibizumab or aflibercept as the protocol for mentenance phase for polypoidal choroidal vasculopathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The total number of dose with ranibizumab or
aflibercept at 52 weeks.
Key secondary outcomes
1)Visual acuity with ETDRS chart. The ratio of the patients with visual acuity improvement with more than or within ten letters.
2)Subretinal hemorrhage,retinal pigment epitherial detachment and retinal atrophy by fundus photography.
3)Evaluation of fluorescein angiography:leakage from the lesion.
4)The ratio of the obstruction of plypoidal lesion at 12 weeks,24 weeks and 52 weeks.
5)The average of retinal sensitivity with MAIA
6)The average of central retinal thickness and and the amount of change of central retinal thickness with SD-OCT.
7)The average of central choroidal thickness and and the amount of change of central choroidal thickness with SD-OCT.
8)The evaluation of macular atrophic lesion with fundus auto fluorescein.
9)The ratio of patients with dry macular.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravitreal injection of ranibizumab
Interventions/Control_2
Intravitreal inection of aflibercept
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 and Female
Key inclusion criteria
1)Subfoveal polypoidal choroidal vasculopathy
2)The patient who did not received the monotherapy or the combination therapy such as anti-VEGF therapy,photo dynamic therapy,retinal photo coaguration or other therapy for retina.
3)The patient with fudus scopical serous retinal detachment, serous or hemorrhagic PED or subretinal hemorrhage.
4)The patinet with serous detachment more than 150 maicrometer at baseline.
5) The patient with 35 letters or more with ETDRS chart or 20/200 or more with Snellen Visual chart
6) The patient with lesion area less than 6230 maicrometer.
Key exclusion criteria
1)The patient with dry AMD,wet AMD with typical AMD or wet AMD with retinal angiomatous proliferation.
2)The patinet with diabetic maculopathy, retinal vein occlusion,macular tellangiectasia.
3)The patient with subfoveal fibrosis or subfoveal atrophy.
4)The patient with moderate or severe cataract.
5)The patient with the possibility of development of secondary choroidal neovascularization, pahological myopia.
6)The patient who received intoraocular surgery 3 months before entry or filtrating surgery.
7)The patient who developed the inflamation
around the eye 4 weeks before entry.
8)The patient who received vitrectomy.
9)The patient who developed reteinal epithelial tear.
10) The patient with below or with the passed history below; severe heart disease, severe peripheral vascular disease, severe renal failure, severe hepatic failure, cerebral infarction before entry or any surgery 1 month before entry.
11)The patient who received radiation therapy for the examination eye.
12)The patient with severe allergy with the contrast medium for fundus angio graphy.
13)The patient who is pregnant or is lactating.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayasu Kitahashi |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 2608670, Japan
TEL
043-222-7171
kitahashi@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayasu Kitahashi |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 2608670, Japan
TEL
043-222-7171
Homepage URL
kitahashi_m@yahoo.co.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Chiba University Graduate School of Medicine
Department of Ophthalmology and Visual Science
Organization
Division
Category of Funding Organization
Self funding
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
YES
Study ID_1
G24047
Org. issuing International ID_1
Chiba University Graduate School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学大学院医学研究院眼科学
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
No entry
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
| 2012 | Year | 11 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 03 | Day |
Last modified on
| 2015 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020194
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| Registered date | File name |
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| Registered date | File name |
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