Unique ID issued by UMIN | UMIN000024208 |
---|---|
Receipt number | 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 19:31:06 |
Ranibizumab Exploratory Study on the Evaluation of the local laser combination therapy to non-reactive group to the diabetic macular edema patients
RELAND study
Ranibizumab Exploratory Study on the Evaluation of the local laser combination therapy to non-reactive group to the diabetic macular edema patients
RELAND study
Japan |
Diabetic Macular edema
Ophthalmology |
Others
NO
To evaluate the effect of ranibizumab and additional focal laser with ranibizumab for DME treatment
Efficacy
The mean change from baseline in best corrected visual acuity (BCVA) at 6 month
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.
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
3
Treatment
Device,equipment | Maneuver |
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.
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.
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.
20 | years-old | <= |
Not applicable |
Male and Female
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
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
100
1st name | |
Middle name | |
Last name | Kazuhiro Kimura |
Department of Ophthalmology, Yamaguchi University Graduate School of Medicine
opthalmology
1-1-1 Minami-Kogushi, Ube City Yamaguchi 755-8505, Japan
0836-22-2278
k.kimura@yamaguchi-u.ac.jp
1st name | |
Middle name | |
Last name | Kazuhiro Kimura |
Department of Ophthalmology, Yamaguchi University Graduate School of Medicine
opthalmology
1-1-1 Minami-Kogushi, Ube City Yamaguchi 755-8505, Japan
0836-22-2278
k.kimura@yamaguchi-u.ac.jp
Yamaguchi University
Novartis Pharmaceuticals Japan
Profit organization
NO
2016 | Year | 11 | Month | 18 | Day |
Unpublished
Open public recruiting
2016 | Year | 06 | Month | 14 | Day |
2016 | Year | 10 | Month | 01 | Day |
2016 | Year | 09 | Month | 28 | Day |
2018 | Year | 10 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027867