Unique ID issued by UMIN | UMIN000016036 |
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Receipt number | R000018185 |
Scientific Title | Prospective study evaluating aflibercept in patients with recurrent or prolonged diabetic macular edema after vitrectomy |
Date of disclosure of the study information | 2015/01/01 |
Last modified on | 2018/12/04 15:45:50 |
Prospective study evaluating aflibercept in patients with recurrent or prolonged diabetic macular edema after vitrectomy
Prospective study evaluating aflibercept in patients with recurrent or prolonged diabetic macular edema after vitrectomy
Prospective study evaluating aflibercept in patients with recurrent or prolonged diabetic macular edema after vitrectomy
Prospective study evaluating aflibercept in patients with recurrent or prolonged diabetic macular edema after vitrectomy
Japan |
Diabetic macular edema
Ophthalmology |
Others
NO
To investigate the usefulness of aflibercept in vitrectomized eyes with recurrent or prolonged diabetic macular edema
Efficacy
Confirmatory
Pragmatic
Phase IV
Change of central macular thickness measured by OCT from baseline to month 6
・Change of best-corrected visual acuity from baseline to month 6
・Proportion of patients with 2-line improvement in best-corrected visual acuity from baseline to month 6
・Proportion of patients with 20% improvement in central macular thickness measured by OCT from baseline to month 6
・Change of retinal sensitivity measured by humphrey (10-2) from baseline to month 6
・Change of subjective symptom by National Eye Institute Visual Functioning Questionnaire 25 (VFQ-25) from baseline to month 6
・Adverse event at moth 6
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Clinicians should inject aflibercept (EYLEA) 2 mg dosed in the eye monthly for 5 initial months and then inject monthly until 12 months after first administration according to following re-injection criteria.
< re-injection criteria >
Clinicians decide additional injection of aflibercept (EYLEA) 2 mg until under 250um in central macular thickness or below 0 in best-corrected logMAR visual acuity.
20 | years-old | <= |
Not applicable |
Male and Female
1) Vitrectomized eye with recurrent or prolonged diabetic macular edema more than 6 months after vitrectomy
( more than 300um in central macular thickness measured by OCT retinal map)
2) 0.2-1.2 in best-corrected logMAR visual acuity
3) Type 1 or Type 2 diabetes mellitus
(20 years and older)
4) Vitrectomy was performed for not proliferative diabetic retinopathy but for diabetic macular edema
5) Written informed consent was obtained
1) Use of any anti VEGF therapy for candidate eyes after vitrectomy
2) Use of any steroid therapy (except for eye drop) for candidate eyes within 3 months prior to initial injection
3) Intraocular,periocular inflammation or infection in candidate eye
4) Allergy history for drug used in this trial
5) Women who are pregnant or breast feeding or who are capable of becoming pregnant
6) Focal, grid laser photocoagulation within 3 months prior to initial injection
7) Proliferative diabetic retinopathy such as vitreous hemorrhage,preretinal hemorrhage,neovascularization, proliferative membrane,tractional retinal detachment
8) Some of optic disc atrophy
9) Cataract that would interfere with required fundus examinations, fundus photographs or OCT
10) Cataract surgery within 6 months prior to initial injection
11) Systematic diseases( sever heart failure, stroke, blood disease, malignant tumor)
12) History of systematic steroids treatment
13) Sever renal failure (serum creatinine>2.0 mg/dL)
14)Presence of uncontrolled hypertension
(systolic>180mmHg,diastolic>110mmHg)
15) HbA1c>10%
16) Considered unsuitable candidate by clinicians
30
1st name | |
Middle name | |
Last name | Yoshida Shigeo |
Kyushu university
Ophthalmology
Fukuoka
092-642-5648
yosida@med.kyushu-u.ac.jp
1st name | |
Middle name | |
Last name | Yoshida Shigeo |
Kyushu university
Ophthalmology
Fukuoka
092-642-5648
yosida@med.kyushu-u.ac.jp
Kyushu university
Bayer Yakuhin Ltd.
Profit organization
NO
九州大学病院
2015 | Year | 01 | Month | 01 | Day |
Unpublished
Completed
2014 | Year | 01 | Month | 19 | Day |
2015 | Year | 02 | Month | 05 | Day |
2019 | Year | 03 | Month | 31 | Day |
2014 | Year | 12 | Month | 23 | Day |
2018 | Year | 12 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018185
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