UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035833 |
|---|---|
| Receipt number | R000022646 |
| Scientific Title | The effect of direct photocoagulation combined with intravitreal injection of anti-VEGF agents for diabetic macular edema |
| Date of disclosure of the study information | 2019/02/11 |
| Last modified on | 2019/02/10 18:25:12 |
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Basic information
Public title
The effect of direct photocoagulation combined with intravitreal injection of anti-VEGF agents for diabetic macular edema
Acronym
Combination therapy of direct photocoagulation and anti-VEGF agents for diabetic macular edema
Scientific Title
The effect of direct photocoagulation combined with intravitreal injection of anti-VEGF agents for diabetic macular edema
Scientific Title:Acronym
Combination therapy of direct photocoagulation and anti-VEGF agents for diabetic macular edema
Region
| Japan |
Condition
Condition
diabetic macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the efficacy of direct photocoagulation combined with anti-VEGF therapy in the treatment of diabetic macular edema.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
retinal thickness, visual acuity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and 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
| Maneuver |
Interventions/Control_1
directphotocoagulation + anti-VEGF therapy
Interventions/Control_2
The duration of additioanal photocoagulation is 6 months after initial injection og ranibizumab.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes who had diabetic macular edema.
Key exclusion criteria
(1) focal/grid photocoagulation, PRP within the previous 12 months, (2) active intraocular inflammation or infection in either eye, (3) uncontrolled glaucoma in either eye, (4) previous treatment with the anti-angiogenic drug (5) a history of stroke, (6) a systolic blood pressure (BP) > 160 mm Hg or a diastolic BP > 100 mm Hg, or untreated hypertension.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Takamura |
Organization
University of Fukui
Division name
Department of Ophthalmology
Zip code
Address
Shimoaizuki, Matsuoka, Yoshida, Fukui
TEL
+81-776-61-8403
ytakamura@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Takamura |
Organization
University of Fukui
Division name
Department of Ophthalmology
Zip code
Address
Shimoaizuki, Matsuoka, Yoshida, Fukui
TEL
+81-776-61-8403
Homepage URL
ytakamura@hotmail.com
Sponsor or person
Institute
University of Fukui, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
University of Fukui, Department of Ophthalmology
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
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 | 02 | Month | 11 | 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 | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 10 | Day |
Last modified on
| 2019 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022646
