UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042801 |
|---|---|
| Receipt number | R000048790 |
| Scientific Title | Epidemiological Study to Evaluate the Prevalence and Progression of Diabetic Macular Ischemia in Patients with Diabetic Retinopathy Treated with Panretinal Photocoagulation |
| Date of disclosure of the study information | 2021/01/12 |
| Last modified on | 2023/12/26 22:44:42 |
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Basic information
Public title
Epidemiological Study to Evaluate the Prevalence and Progression of Diabetic Macular Ischemia in Patients with Diabetic Retinopathy Treated with Panretinal Photocoagulation
Acronym
EYE DMI
Scientific Title
Epidemiological Study to Evaluate the Prevalence and Progression of Diabetic Macular Ischemia in Patients with Diabetic Retinopathy Treated with Panretinal Photocoagulation
Scientific Title:Acronym
EYE DMI
Region
| Japan | Asia(except Japan) | North America |
| Europe |
Condition
Condition
Diabetic Macular Ischemia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main objectives are to estimate the prevalence of diabetic macular ischemia (DMI) in patients with diabetic retinopathy (DR) treated with panretinal photocoagulation (PRP) and to evaluate the functional and morphological changes in the eye during a 12-month period. This study has two parts: Part A involves a cross-sectional analysis and Part B involves a follow-up analysis, with the following objectives:
1. Among patients with DR, to describe baseline characteristics of patients and quantify the prevalence of DMI at baseline
2. Among patients with DMI, to characterize change in visual acuity under normal and low-luminance conditions during 12 months of follow-up
Basic objectives2
Others
Basic objectives -Others
1. Among patients with DMI, to identify risk factors for change in visual acuity during 12 months of follow-up
2. Among patients with DMI, to characterize changes in morphological parameters, as generated by optical coherence tomography angiography (OCTA) and spectral domain optical coherence tomography (SD-OCT) during 12 months of follow-up
3. Among patients with DMI and diabetic macular edema (DME) who have undergone anti-vascular endothelial growth factor (anti-VEGF) therapy during 12 months of follow-up, to reevaluate the baseline assessment of DMI after the resolution of DME
Among patients with DMI, key subgroups are patients categorized according to DMI severity and DME, with and without central involvement (CI).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Best Clinic Visual Acuity
Best Clinic Visual Acuity is measured with glasses and with pinhole occluder (if glasses are regularly worn) or unaided and with pinhole occluder (if glasses are not regularly worn)
Change in Visual Acuity under normal light condition will be measured by the number of letters read from an ETDRS chart
Low-Luminance Best Clinic Visual Acuity
Low-Luminance Visual Acuity is the Best Clinic Vision with a mesopic filter added to the ETDRS Cabinet.
Change in Visual Acuity under low-luminance condition will be measured by the number of letters read from an ETDRS chart, applying a mesopic filter.
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
Inclusion criteria for Part A cross-sectional:
Adults =/>18 years (=/>20 years old in Japan)
Treated with PRP for DR in previous five years (but not in the six months before patient enrollment)*
Inclusion criteria for Part B follow-up:
Fifty-four letters or better based on Best Clinic Visual Acuity (using Early Treatment Diabetic Retinopathy Study [ETDRS] chart)*
DMI, defined as a foveal avascular zone (FAZ) with =/>0.5mm2 area in superficial capillary plexus, on OCTA (Optovue AngioVue). If FAZ is <0.5mm2, then enlarged peri-foveal inter-capillary space in at least one quadrant will be sufficient*
Key exclusion criteria
Exclusion criteria (Part A and B):
Patients currently participating in an interventional trial with an ophthalmologic experimental therapy
Exclusion criteria (Part B only):
Severe DRIL, i.e., affecting 50% or more of the central one-mm-wide zone centered on the fovea (foveal DRIL), as defined by Sun et al. [R19-4048]*
Any concurrent macular abnormality other than DMI and DME that, in the opinion of the investigator, would interfere with the assessment of DMI and DME (e.g., significant macular epiretinal membrane, neovascular age-related macular degeneration, and macular hemorrhage)*
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Ogura |
Organization
Nagoya City University Hospital
Division name
Ophthalmology Department
Zip code
467-8602
Address
1, Kawasumi Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
052-851-5511
yasuzumi.shimizu@iqvia.com
Public contact
Name of contact person
| 1st name | Yasuzumi |
| Middle name | |
| Last name | Shimizu |
Organization
IQVIA Services Japan, K.K.
Division name
Real-World Evidence Services, Real-World Analytics Solutions
Zip code
108-0074
Address
3-4-30, Miyahara Yodogawa-ku Osaka, Japan, 532-0003
TEL
080-4409-9223
Homepage URL
yasuzumi.shimizu@iqvia.com
Sponsor or person
Institute
Boehringer Ingelheim International GmbH
Institute
Department
Personal name
Funding Source
Organization
Boehringer Ingelheim International GmbH
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Hospital
Address
1, Kawasumi Mizuho-cho, Mizuho-ku, Nagoya, Aichi
Tel
052-851-5511
NA
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
| 2021 | Year | 01 | Month | 12 | 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
539
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
under preparation
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nagata Eye Clinic (Nara)
Ikuno Eye Center (Osaka)
Management information
Registered date
| 2020 | Year | 12 | Month | 21 | Day |
Last modified on
| 2023 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048790
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