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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000017818 |
Receipt No. | R000020638 |
Scientific Title | Anti-VEGF monotherapy versus combined anti-VEGF and end-point-management grid laser photocoagulation for diabetic macular edema |
Date of disclosure of the study information | 2015/06/05 |
Last modified on | 2017/06/05 |
Basic information | |||
Public title | Anti-VEGF monotherapy versus combined anti-VEGF and end-point-management grid laser photocoagulation for diabetic macular edema | ||
Acronym | END-DME Study | ||
Scientific Title | Anti-VEGF monotherapy versus combined anti-VEGF and end-point-management grid laser photocoagulation for diabetic macular edema | ||
Scientific Title:Acronym | END-DME Study | ||
Region |
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Condition | ||
Condition | Diabetic macular edema | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To compare the efficacy of monotherapy with anti-VEGF (ranibizumab or bevacizumab) with combined therapy with anti-VEGF and end-point-management grid laser photocoagulation for diabetic macular edema. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Difference in number of Anti-VEGF injections required among the two treatment arms. |
Key secondary outcomes | Change from baseline in BCVA and OCT.
Time required achieving treatment success. BCVA and OCT outcome depending on the type of DME on presentation. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |||
No. of arms | 2 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
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Interventions/Control_1 | anti-VEGF monotherapy | ||
Interventions/Control_2 | anti-VEGF therapy and End-Point-Management (EPM) grid laser photocoagulation | ||
Interventions/Control_3 | |||
Interventions/Control_4 | |||
Interventions/Control_5 | |||
Interventions/Control_6 | |||
Interventions/Control_7 | |||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | To be eligible, the following inclusion criteria must be met:
Age; 18 years with CSME Diagnosis of diabetes mellitus (type 1 or type 2) At least one eye meets the study eye criteria Able and willing to provide informed consent prior to any study-related procedures Central foveal thickness; 300 microns at baseline (SPECTRALIS or Cirrus HD OCT) LogMAR Best corrected visual acuity 0.30 (Snellen 20/25) to 1.3 (Snellen 20/400). Willing and able to comply with clinic visits and study-related procedures Central Foveal Thickness on OCT 300-600 micron After first injection, wait for ME to reduce before proceeding with the laser. Exclude if ME persists >500um at the 4-week follow up |
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Key exclusion criteria | Macular edema is considered to be due to a cause other than diabetic macular edema. An ocular condition is present such that visual acuity loss would not improve from resolution of macular edema. Substantial cataract that is likely to be affecting visual acuity.
Focal laser photocoagulation should be performed before enrolling into the study if needed. Three months gap required between last laser procedure and recruitment. History of panretinal (scatter) photocoagulation (PRP) within 3 months prior to enrollment. Anticipated need for PRP in the study period. History of major retinal surgery. History of YAG capsulotomy performed within 3 months. Aphakia. History of open-angle glaucoma. Exam evidence of external ocular infection. A subject is not eligible if any of the following exclusion criteria are present Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. A condition that would preclude participation in the study. Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months. Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization. pregnant or lactating or intending to become pregnant within the next 12 months. |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | University of Hong Kong, Nagoya City University Graduate School of Medical Sciences | ||||||
Division name | Ophthalmology | ||||||
Zip code | |||||||
Address | 1 Kawasumi Mizuhocho Mizuho-ku Nagoya | ||||||
TEL | 052(853)8251 | ||||||
nozakim@med.nagoya-cu.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Nagoya City University Graduate School of Medical Sciences | ||||||
Division name | Ophthalmology | ||||||
Zip code | |||||||
Address | 1 Kawasumi Mizuo-cho Mizuho-ku Nagoya | ||||||
TEL | 052(853)8251 | ||||||
Homepage URL | |||||||
nozakim@mednagoya-cu.ac.jp |
Sponsor | |
Institute | University of Hong Kong, Nagoya City University Graduate school of Medical Sciences |
Institute | |
Department |
Funding Source | |
Organization | none |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
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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 | 杏林大学アイセンター(東京都)、京都大学(京都府)、旭川医大(北海道)、福井大(福井県)
北海道大学(北海道)東京医科大学八王子医療センター(東京都) 九州大学(福岡県)、大阪医大(大阪府)江口眼科病院(北海道)、山形大(山形県)、長崎大(長崎県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020638 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |