UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012751 |
|---|---|
| Receipt number | R000014901 |
| Scientific Title | Indocyanine Green Angiography-Guided Assessment and Laser Photocoagulation for Diabetic Macular Edema: a pilot study |
| Date of disclosure of the study information | 2014/01/06 |
| Last modified on | 2014/01/04 08:22:44 |
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Basic information
Public title
Indocyanine Green Angiography-Guided Assessment and Laser Photocoagulation for Diabetic Macular Edema: a pilot study
Acronym
ICG-guided Laser Photocoagulation for Diabetic Macular Edema
Scientific Title
Indocyanine Green Angiography-Guided Assessment and Laser Photocoagulation for Diabetic Macular Edema: a pilot study
Scientific Title:Acronym
ICG-guided Laser Photocoagulation 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 evaluate the usefulness of indocyanine green angiography (ICGA)-guided assessment and laser photocoagulation for diffuse diabetic macular edema.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Best corrected visual acuity and central retinal thickness and macular volume measured by optical coherence tomography
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
Laser photocoagulation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with diffuse DME diagnosed on FA and a baseline best-corrected visual acuity (BCVA) of 20/400 to 20/30 were enrolled.
Key exclusion criteria
Eyes, which underwent scattered (panretinal) laser photocoagulation within 6 months prior to enrollment and which had hazy media because of corneal opacity, moderate to severe cataract, or dense vitreous hemorrhage, interfering with laser photocoagulation; and patients, who had any possible histories of allergic reaction to fluorescein dye, indocyanine green dye, or both.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Yasukawa |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Ophthalmology and Visual Science
Zip code
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601, JAPAN
TEL
+81-52-8538251
yasukawa@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Yasukawa |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Ophthalmology and Visual Science
Zip code
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601, JAPAN
TEL
+81-52-8538251
Homepage URL
yasukawa@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Graduate School of Medical Sciences
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
| 2014 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2009 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 04 | Day |
Last modified on
| 2014 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014901
