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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036143
Receipt No. R000041177
Scientific Title Comparisons of changes in circulating vascular endothelial growth factor-A and renal vascular parameters after intravitreal ranibizumab or aflibercept for retinal vascular disease
Date of disclosure of the study information 2019/03/10
Last modified on 2019/03/10

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Basic information
Public title Comparisons of changes in circulating vascular endothelial growth factor-A and renal vascular parameters after intravitreal ranibizumab or aflibercept for retinal vascular disease
Acronym Comparisons of changes in circulating vascular endothelial growth factor-A and renal vascular parameters after intravitreal ranibizumab or aflibercept for retinal vascular disease
Scientific Title Comparisons of changes in circulating vascular endothelial growth factor-A and renal vascular parameters after intravitreal ranibizumab or aflibercept for retinal vascular disease
Scientific Title:Acronym Comparisons of changes in circulating vascular endothelial growth factor-A and renal vascular parameters after intravitreal ranibizumab or aflibercept for retinal vascular disease
Region
Japan

Condition
Condition age-related macular degeneration, diabetic macular edema, macular edema secondary to retinal vein occlusion
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the changes in the circulating total VEGF-A, VEGF-A165b, blood pressure, ankle brachial index, and albuminuria levels after intravitreal ranibizumab or aflibercept for retinal vascular diseases.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Urine albumin to creatinine ratio 3 months after treatment
Key secondary outcomes 1)Circulating total VEGF-A and VEGF-A165b levels 3 months after treatment
2)Blood pressure 3 months after treatment
3)Ankle brachial index 3 months after treatment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Three monthly intravitreal injections of ranibizumab(0.5 mg/0.05 ml)
Interventions/Control_2 Three monthly intravitreal injections of aflibercept(2.0 mg/0.05 ml)
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
40 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients who had not received prior intravitreal anti-VEGF therapy.
2)Patients with normoalbuminuria or microalbuminuria according to the 2012 Kidney Disease Improving Global Outcomes guideline(A1+A2 categories, KDIGO 2012).
Key exclusion criteria 1)Patients who had received systemic anti-VEGF therapy for malignancy.
2)Patients who were currently on dialysis.
3)Patients who had undergone vitrectomy in the treated eye.
4)Patients who had severely high albuminuria (A3 category, KDIGO 2012).
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinsuke Ozawa
Organization Tosei General Hospital
Division name Department of Ophthalmology
Zip code
Address 160 Nishioiwake-cho, Seto, Aichi, Japan
TEL 0561-82-5101
Email sp3n5xq9@jupiter.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinsuke Ozawa
Organization Tosei General Hospital
Division name Department of Ophthalmology
Zip code
Address 160 Nishioiwake-cho, Seto, Aichi, Japan
TEL 0561-82-5101
Homepage URL
Email sp3n5xq9@jupiter.ocn.ne.jp

Sponsor
Institute Tosei General Hospital
Institute
Department

Funding Source
Organization Japan Foundation for Applied Enzymology
Organization
Division
Category of Funding Organization Non profit foundation
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
2019 Year 03 Month 10 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
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
2015 Year 08 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 30 Day
Last follow-up date
2017 Year 07 Month 03 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 10 Day
Last modified on
2019 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041177

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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