UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036143 |
|---|---|
| Receipt number | 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 14:20:16 |
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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
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
sp3n5xq9@jupiter.ocn.ne.jp
Sponsor or person
Institute
Tosei General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041177
