UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025490 |
|---|---|
| Receipt number | R000029333 |
| Scientific Title | Evaluation of morphological-based treatment regimen of aflibercept in patients with diabetic macular edema |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2020/03/28 21:13:14 |
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Basic information
Public title
Evaluation of morphological-based treatment regimen of aflibercept in patients with diabetic macular edema
Acronym
Morphological-based aflibercept treatment for DME
Scientific Title
Evaluation of morphological-based treatment regimen of aflibercept in patients with diabetic macular edema
Scientific Title:Acronym
Morphological-based aflibercept treatment for DME
Region
| Japan |
Condition
Condition
Diabetic Macular Edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate unique treatment regimen of aflibercept for diabetic macular edema, morphological based monthly injections as loading, and subsequent bimonthly injections as maintenance phase.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Improvement of logMAR visual acuity at 12 months
Key secondary outcomes
Ratio of patients who gained VA >logMAR0.2 at 12 months
Dynamic change of central macular thicknes (CMT) during the clinical course of 12 months
The requied number of initial contiuous injections of aflibercept to obtain CMT <300 micrometer
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
patients with diabetic macular edema with central macular thickness more than 400 micrometer and best corrected visual acuity between logMAR 0.15 and 1.2
Key exclusion criteria
Vitrectomized eye
Previous anti-VEGF therapy
Previous any treatment for DME before 90 days
Pregnant or potentially pregnant
Uncontrolled general condition
Ocular inflammation
Active proliferative diabetic retinopathy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Shimura |
Organization
Tokyo Medical University, Hachioji Medical Center
Division name
Depatment of Ophthalmology
Zip code
1930998
Address
1163 Tate-machi, Hachioji, Tokyo
TEL
0426655611
masahiko@v101.vaio.ne.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Shimura |
Organization
Tokyo Medical University, Hachioji Medical Center
Division name
Depatment of Ophthalmology
Zip code
1850012
Address
1163 Tate-machi, Hachioji, Tokyo
TEL
0426655611
Homepage URL
masahiko@v101.vaio.ne.jp
Sponsor or person
Institute
Department of Ophthalmology
Tokyo Medical University, Hachioji Medical Center
Institute
Department
Personal name
Funding Source
Organization
Byer Pharmaceutical
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board in Tokyo Medical University Hachioji Medical Center
Address
1163 Tate-machi, Hachioji, Tokyo
Tel
0426655611
masahiko@v101.vaio.ne.jp
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
| 2017 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
under construction
Publication of results
Published
Result
URL related to results and publications
under construction
Number of participants that the trial has enrolled
49
Results
Mean improvement from baseline visual acuity at 12 month was 0.17 plus/minus 0.24 logMAR (8.5 letters). Proportion of eyes gained more than 0.3 logMAR was 30.6%, and lost over 0.3 logMAR was 4.1%. Eighteen eyes (36.7%) showed prompt regression of CMT soon after the 1st aflibercept injection, while 7 eyes (14.3%) required 6 continuous injections at loading phase. Total required number of aflibercept injection averaged 7.14 plus/minus 1.08 times.
Results date posted
| 2020 | Year | 03 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients with DME, of which central macular thickness (CMT) > 400 micro meter and best corrected visual acuity (BCVA) ranged 0.3-1.0 logMAR.
Participant flow
56 patients were recrtuited and 49 cases were completed in this study
Adverse events
There were no systemic adverse effect. Also, no ocular adverse effects in relation to this study protocol were not reported.
Outcome measures
Primary outcome measures
Averaged improvement of visual acuity from baseline
secondary outcome measures
proportion of eyes gained visual acuity more than 0.3 logMAR
Averaged reduction of macular thickness from baseline
require number of drug injection for obtaining macular thickness less than 300 micro meter
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 23 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 14 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 28 | Day |
Other
Other related information
As a initial phase, initial monthly aflibercept injections up to CMT less than 300 mocrometer but maximum 5 continuous injections
After that, as a maintenance phase, subsequent bimonthly aflibercept injections
Management information
Registered date
| 2016 | Year | 12 | Month | 31 | Day |
Last modified on
| 2020 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029333
