UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020787 |
|---|---|
| Receipt number | R000023955 |
| Scientific Title | Efficacy and safety in adequate regimen of aflibercept therapy for patients with diabetic macular edema |
| Date of disclosure of the study information | 2016/01/29 |
| Last modified on | 2016/01/29 00:04:26 |
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Basic information
Public title
Efficacy and safety in adequate regimen of aflibercept therapy for patients with diabetic macular edema
Acronym
Adequate aflibercept therapy for DME
Scientific Title
Efficacy and safety in adequate regimen of aflibercept therapy for patients with diabetic macular edema
Scientific Title:Acronym
Adequate aflibercept therapy for DME
Region
| Japan |
Condition
Condition
diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the adequate regimen in aflibercept intravitreal injection for diabetic macular edema and to evaluate the decrease of number of injections and the improvement in visual acuity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in best-corrected visual acuity from baseline to six months or 12 months after the initial injection
Key secondary outcomes
Proportion of improvement or no change or worsening in change of best-corrected visual acuity from baseline to six months or 12 months after the initial injection
Change in fluorescin angiography and optical coherence tomography (OCT)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients with diabetic macular edema receive bi-monthly aflibercept intravitreal injections.
When the best-corrected visual acuity worsen more than 0.3 logMAR visual acuity one month after each injection, the patients receive aflibercept injection.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Definite retinal thickening due to diabetic macular edema on clinical examination involving the center of the macula assessed to be the main cause of visual loss.
Best-corrected logMAR visual acuity in baseline > 0.22.
Retinal thickness measured on spectral domain optical coherence tomography > 300 micron in the central subfield.
Key exclusion criteria
Anti-VEGF therapy within the prior 3 months.
Retinal photocoagulation within the prior 3 months.
Steroid therapy within the prior 3 months.
Major ocular surgery within the prior 3 months.
A myocardial infarction or other cardiac event requiring hospitalization.
Cerebrovascular accident, transient ischemic attack, or acute congestive heart failure.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Sawada |
Organization
Shiga University of Medical Science
Division name
Ophthalmology
Zip code
Address
Seta Tukinowacho, Otsu, Shiga
TEL
077-548-2276
osawada@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Sawada |
Organization
Shiga University of Medical Science
Division name
Ophthalmology
Zip code
Address
Seta Tsukinowacho, Otsu, Shiga
TEL
077-548-2276
Homepage URL
osawada@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Health, Labour and Welfare Ministry
Organization
Division
Category of Funding Organization
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
滋賀医科大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 29 | Day |
Last modified on
| 2016 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023955
