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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031210235

Registered date:11/08/2021

Prospective clinical trial of Eylea combined with Vitrectomy for DME

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studieddiabetic macular edema
Date of first enrollment01/09/2021
Target sample size10
Countries of recruitment
Study typeInterventional
Intervention(s)Vitrectomy is performed to the case of diabetic macular edema with inadequate effects of anti-VEGF agents. Observation is performed every 4 weeks. Administer anti-VEGF agent if retreatment criteria are met.

Outcome(s)

Primary OutcomeChange in best corrected visual acuity (logMAR) from baseline (before vitrectomy)
Secondary OutcomeChange in central retinal thickness from baseline (before vitrectomy) Number of anti-VEGF treatment after vitrectomy

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 80age old
GenderBoth
Include criteria1) Japanese male and female of 20 to 80 years 2) DME with central involvement in the study eye 3) Patients with a central retinal thickness (CRT) of 400 micrometer or more after 3 consecutive injections of Eylea, or patients with a CRT increases of 30% or more within 16 weeks even if the CRT decreased to less than 400 micrometers after 3 consecutive injections of Eylea In cases that both eyes meet inclusion criteria and vitrectomy is performed to both eyes, the subject is only one eye, and in principle, the eye to be operated on first is the subject eye
Exclude criteria1) New patient 2) Last-eye patient (one-eye blindness) 3) Poor glycemic control (HbA1c 9.0% or higher) 4) Uncontrolled hypertension (systolic blood pressure> 180 mmHg or diastolic blood pressure> 110 mmHg) 5) Dialysis patients or patients with severe renal dysfunction who are considering the introduction of dialysis 6) Patients with thickened epiretinal membrane or posterior vitreous membrane in the study eye, without retinal edema in their OCT images, with less than 10% improvement in central retinal thickness by 3 consecutive injections of anti-VEGF agents 7) Patients with cataracts that clearly affect visual acuity in the study eye 8) Patients who underwent panretinal photocoagulation within 180 days of vitrectomy in the study eye 9) Patients who received intraocular or periocular steroids within 120 days of vitrectomy in the study eye 10) Patients who underwent cataract surgery or other intraocular surgery within 90 days of vitrectomy in the study eye 11) Patients who have a history of filtration surgery for the treatment of glaucoma in the study eye, or who are expected to need it in the future 12) Patients with a history of idiopathic or autoimmune uveitis in the study eye 13) Patients with iris neovascularization and tractional retinal detachment in the study eye 14) Patients with central macular structural damage such as retinal pigment epithelial atrophy, subretinal fibrosis or scarring, severe macular ischemia or organic hard macula that interferes with visual acuity improvement after macular edema disappears in the study eye 15) Patients with marked fluctuations in symptoms and findings 16) Patients who cannot understand the contents and procedures of this study 17) Patients who are participating in the other research 18) Patients who have difficulty going to the hospital 19) Patients who are judged by the investigator or the investigator to be unsuitable for conducting this study safely

Related Information

Contact

Public contact
Name Tomoaki Tatsumi
Address 1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan Chiba Japan 260-8677
Telephone +81-43-222-7171
E-mail ttatsumi@chiba-u.jp
Affiliation Chiba University Hospital
Scientific contact
Name Takayuki Baba
Address 1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan Chiba Japan 260-8677
Telephone +81-43-222-7171
E-mail babatakayuki@nifty.com
Affiliation Chiba University Hospital