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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042801
Receipt No. 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 2020/12/21

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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
Email Mika.Omori@iqvia.com

Public contact
Name of contact person
1st name Mika
Middle name
Last name Omori
Organization IQVIA Services Japan, K.K.
Division name Real-World Evidence Services, Real-World Analytics Solutions
Zip code 108-0074
Address 4-10-18 Keikyu Dai-ichi Bldg., Minato-ku, Tokyo
TEL 080-2482-7169
Homepage URL
Email Mika.Omori@iqvia.com

Sponsor
Institute Boehringer Ingelheim International GmbH
Institute
Department

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
Email 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
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 Preinitiation
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
2022 Year 09 Month 30 Day
Date of closure to data entry
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
2020 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048790

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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