UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029818 |
|---|---|
| Receipt number | R000034067 |
| Scientific Title | Intravitreal triamcinolone acetonide combined withccataract surgery for diabetic macular edema |
| Date of disclosure of the study information | 2017/11/04 |
| Last modified on | 2018/08/15 20:05:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Intravitreal triamcinolone acetonide combined withccataract surgery for diabetic macular edema
Acronym
IVTA with cataract for DME
Scientific Title
Intravitreal triamcinolone acetonide combined withccataract surgery for diabetic macular edema
Scientific Title:Acronym
IVTA with cataract 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 the effectiveness of an intravitreal triamcinolone acetonide injection (IVTA) combined with cataract surgery for the diabetic macular edema (DME) resist to anti-vascular endothelial growth factor (anti-VEGF).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity after treatment
Key secondary outcomes
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
All of the patients had received IVTA combined with phacoemulsification and aspiration cataract surgery and intraocular lens implantation between December 2014 and December 2016. The inclusion criteria were patients who were resistant to previous treatments such as retinal photocoagulation, intravitreal injections of anti-VEGF agents, or sub-tenon triamcinolone acetonide injections(STTA), had a medical history of systemic diseases such as myocardial infarction, cerebral infarction, or cerebral hemorrhage, and had financial difficulty in paying for the anti-VEGF treatments. The CRT of all the patients was over 300 um as determined by fluorescein angiography(FAG)and optical coherence tomography(OCT). A recurrence was defined as an increase in the CRT by 20% compared to the minimum CRT value during the observation period.
Key exclusion criteria
Patients were excluded if they had the macular traction syndrome, active proliferative diabetic retinopathy, uveitis, poorly controlled ocular hypertension, glaucoma, had intraocular surgery within the past 6 months, and history of anti-VEGF treatment or STTA, or had macular photocoagulation within the past 3 months before the beginning of the treatment. Patients who had adverse reactions to steroids were also excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Sugimoto |
Organization
Mie University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-174 Edobashi, Tsu, 514-8507, Japan
TEL
059-232-1111
sugmochi@aqua.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Sugimoto |
Organization
Mie University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-174 Edobashi, Tsu, 514-8507, Japan
TEL
059-232-1111
Homepage URL
sugmochi@aqua.ocn.ne.jp
Sponsor or person
Institute
Department of Ophthalmology, Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Mie University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 11 | Month | 04 | 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 | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 11 | Month | 03 | Day |
Last modified on
| 2018 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034067
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
