Diabetic macular edema
Conditions
Interventions
visual acuity with the Landolt chart at every visit Central macular thickness (CMT) by Spectral Domain-OCT at every visit Contrast sensitivity by CSV-1000LV chart at every visit Vision-related qual
Sponsors
University of Tsukuba
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Adults more than 20 years with type 1 or 2 diabetes mellitus 2.Subjects with DME secondary to diabetes mellitus involving the center of the macula defined as the area of the center subfield of OCT in the study eye 3.Decrease in vision determined to be primarily the result of DME in the study eye 4.BCVAmore than 24 letters 5.Central retinal thickness as assessed by OCT of more than 300 in the study eye 6.Willing and able to comply with clinic visits and study related procedures 7.Provide a signed informed consent form after receiving a explanation about this study
Exclusion criteria
Exclusion criteria: (1)The study eye is better than fellow eye (2)History of vitreoretinal surgery (3)Laser photocoagulation in the study eye within 90 days before Day 1 (4)More than 1 treatment with Direct laser/grid laser (5)Previous use of intraocular or periocular corticosteroids in the study eye within 120 days (6)Previous treatment with anti-angiogenic drugs in either eye within 90 days (7)Proliferative diabetic retinopathyin the study eye, (8)History of idiopathic or autoimmune uveitis (9)Any intraocular surgerywithin 90 days before Day 1 (10)Aphakia (11)Vitreomacular traction (12)Current iris neovascularization, vitreoushemorrhage, or tractional retinal detachment (13)Pre-retinal fibrosis (14)Structural damage to the center of the macula (15)History of endophthalmitis (16)Infectious blepharitis, keratitis,scleritis or conjunctivitis (17)Uncontrolled graucoma (18)High intraocular pressure in the study ey (19)High myopia (20)History of disease that can result in decreased visual acuity (21)Only one functional eye (22)Ocular media insufficient to obtain fundus and OCT images in the study eye (23)Serious systemic infection (24)Administration of systemic anti-angiogenic agents within 180 days before day 1 (25)Uncontrolled blood pressure (26)Uncontrolled diabetes mellitus (27)History of cerebrovascular accident and/or Myocardial infarction within 180 days before day 1 (28)Renal failure (29)Systemic disease patients who need treatment that may affect outcomes (30)Pregnant or breast-feeding women (31)Female subjects wish for a pregnancy within the intended treatment period (32)Allergy to fluorescein (33)Hypersensitive to aflibercept (34)Previous participation in any studies of investigational drugs within 30 days preceding Day 1 (35)Subjects who judged by a investigator to be inappropriate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Contrast sensitivity from baseline to 12 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual acuity from baseline to 12 month Central macular thickness(CMT) from baseline to 12 month Contrast sensitivity at every visit Vision-related quality of life (VR-QOL) from baseline to 12 month | — |
Countries
Japan
Contacts
Public ContactFumiki Okamoto
University of Tsukuba Department of Ophthalmology, Faculty of Medicine
Outcome results
None listed