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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024208
Receipt No. R000027867
Scientific Title Ranibizumab Exploratory Study on the Evaluation of the local laser combination therapy to non-reactive group to the diabetic macular edema patients
Date of disclosure of the study information 2016/11/18
Last modified on 2018/10/01

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Basic information
Public title Ranibizumab Exploratory Study on the Evaluation of the local laser combination therapy to non-reactive group to the diabetic macular edema patients
Acronym RELAND study
Scientific Title Ranibizumab Exploratory Study on the Evaluation of the local laser combination therapy to non-reactive group to the diabetic macular edema patients
Scientific Title:Acronym RELAND study
Region
Japan

Condition
Condition Diabetic Macular edema
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of ranibizumab and additional focal laser with ranibizumab for DME treatment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The mean change from baseline in best corrected visual acuity (BCVA) at 6 month
Key secondary outcomes The mean change from baseline in central retinal thickness (CRT) based on SD-OCT at 6 month. The number of injections, and the number of laser treatment at 6 month.

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 3
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 This is a 6 months, prospective, interventional, exploratory, consecutive case series study, and followed by 6 months extension. Patients receive ranibizumab once a month during first two months. After three consecutive monthly injection of ranibizumab, patients are classified into two groups: "Initial responder" and "Initial non-responder".
Initial responder is defined that an improvement of more than 5 letters in BCVA or a decrease of at least 20% in CRT from baseline.
1)Initial responder: After three monthly injections, ranibizumab treatment is continued until macula becomes dry (Dry means CRT=<250um). After that, the injection is continued pro re nata (PRN) regimen. (Retreatment criteria of intravitreal ranibizumab is CRT=>250um)
2)Initial non-responder: After three consecutive monthly injections, FA is performed to clarify the vascular leak from microaneurysm close to macula edema or avascular area at Month 3 visit. Patients are treated with additional focal laser to microaneurysm and avascular area in edema region by judging from FA, fundus photograph and SD-OCT at this visit, if these regions are applicable for focal laser. After focal laser, ranibizumab injection is given at this visit followed by ranibizumab injections by same manner in "initial responder". Otherwise, if focal laser is not applicable to the regions based on the examinations, patients receive ranibizumab injections by similar manner in "initial responder". Focal laser treatment is able to be performed at intervals no shorter than 3 months from the first focal laser.
Laser condition: power80-100mA, spot size 50-100um, duration 0.1second, Area Centralis/TransEquater as lens.
Fundus condition has to be estimated by FA, SD-OCT and fundus photograph during examination. If patient lose therapeutic effect during only ranibizumab therapy, focal laser have to be performed after examination.
Interventions/Control_2 This is a 6 months, prospective, interventional, exploratory, consecutive case series study, and followed by 6 months extension. Patients receive ranibizumab once a month during first two months. After three consecutive monthly injection of ranibizumab, patients are classified into two groups: "Initial responder" and "Initial non-responder".
Initial responder is defined that an improvement of more than 5 letters in BCVA or a decrease of at least 20% in CRT from baseline.
1)Initial responder: After three monthly injections, ranibizumab treatment is continued until macula becomes dry (Dry means CRT=<250um). After that, the injection is continued pro re nata (PRN) regimen. (Retreatment criteria of intravitreal ranibizumab is CRT=>250um)
2)Initial non-responder: After three consecutive monthly injections, FA is performed to clarify the vascular leak from microaneurysm close to macula edema or avascular area at Month 3 visit. Patients are treated with additional focal laser to microaneurysm and avascular area in edema region by judging from FA, fundus photograph and SD-OCT at this visit, if these regions are applicable for focal laser. After focal laser, ranibizumab injection is given at this visit followed by ranibizumab injections by same manner in "initial responder". Otherwise, if focal laser is not applicable to the regions based on the examinations, patients receive ranibizumab injections by similar manner in "initial responder". Focal laser treatment is able to be performed at intervals no shorter than 3 months from the first focal laser.
Laser condition: power80-100mA, spot size 50-100um, duration 0.1second, Area Centralis/TransEquater as lens.
Fundus condition has to be estimated by FA, SD-OCT and fundus photograph during examination. If patient lose therapeutic effect during only ranibizumab therapy, focal laser have to be performed after examination.
Interventions/Control_3 This is a 6 months, prospective, interventional, exploratory, consecutive case series study, and followed by 6 months extension. Patients receive ranibizumab once a month during first two months. After three consecutive monthly injection of ranibizumab, patients are classified into two groups: "Initial responder" and "Initial non-responder".
Initial responder is defined that an improvement of more than 5 letters in BCVA or a decrease of at least 20% in CRT from baseline.
1)Initial responder: After three monthly injections, ranibizumab treatment is continued until macula becomes dry (Dry means CRT=<250um). After that, the injection is continued pro re nata (PRN) regimen. (Retreatment criteria of intravitreal ranibizumab is CRT=>250um)
2)Initial non-responder: After three consecutive monthly injections, FA is performed to clarify the vascular leak from microaneurysm close to macula edema or avascular area at Month 3 visit. Patients are treated with additional focal laser to microaneurysm and avascular area in edema region by judging from FA, fundus photograph and SD-OCT at this visit, if these regions are applicable for focal laser. After focal laser, ranibizumab injection is given at this visit followed by ranibizumab injections by same manner in "initial responder". Otherwise, if focal laser is not applicable to the regions based on the examinations, patients receive ranibizumab injections by similar manner in "initial responder". Focal laser treatment is able to be performed at intervals no shorter than 3 months from the first focal laser.
Laser condition: power80-100mA, spot size 50-100um, duration 0.1second, Area Centralis/TransEquater as lens.
Fundus condition has to be estimated by FA, SD-OCT and fundus photograph during examination. If patient lose therapeutic effect during only ranibizumab therapy, focal laser have to be performed after examination.
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 1) patients who have diabetes, and have developed in at least one eye diabetic macular edema Patients
2) does not recognize the acute myocardial infarction and cerebral infarction within the onset 3 months
Patient age is greater than or equal to 20 years of age at the time of
3) obtaining informed consent
4) gender unquestioned
5) After having received a sufficient explanation Upon participation in the present study, patients on the full understanding, the document agreed by the free will of the patient himself was obtained
6) hospitalization, outpatient unquestioned
Key exclusion criteria 1) Patients with a treatment history of anti VEGF drugs patients
2) Patients with infection or infection suspictions in the eye or around the eye
3) Patients with severe inflammation in the eye
4) DME disease duration is more than 12 months
5) Patients who underwent direct photocoagulation to 3 months in DME within 1000um from the fovea
6) Patients who underwent triamcinolone acetonide subtenon injection or triamcinolone acetonide intravitreal injectionwithin 3 months
7) Patients who underwent PRP within 6 months
8) HbA1c is over 10.0%
9) Poor control of hypertension
10) Eye surgery within 6 months
11) ranibizumab or to the components of other anti-VEGF drugs, those with a history of hypersensitivity
12) Pregnancy, in nursing
13) Other, patient research responsibility who is determined to be unsuitable as research subjects
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Kimura
Organization Department of Ophthalmology, Yamaguchi University Graduate School of Medicine
Division name opthalmology
Zip code
Address 1-1-1 Minami-Kogushi, Ube City Yamaguchi 755-8505, Japan
TEL 0836-22-2278
Email k.kimura@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Kimura
Organization Department of Ophthalmology, Yamaguchi University Graduate School of Medicine
Division name opthalmology
Zip code
Address 1-1-1 Minami-Kogushi, Ube City Yamaguchi 755-8505, Japan
TEL 0836-22-2278
Homepage URL
Email k.kimura@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University
Institute
Department

Funding Source
Organization Novartis Pharmaceuticals Japan
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 11 Month 18 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 Open public recruiting
Date of protocol fixation
2016 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 28 Day
Last modified on
2018 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027867

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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