Diabetic Macular Edema
Conditions
Interventions
None listed
Sponsors
Department of Ophthalmology, Mie University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Adults (age over 20 years) with type 1 or 2 diabetes mellitus who have provided informed consent 2)Subjects with the following retinopathy as shown by fundoscopy with pupil dilation and also with MAs with fluorescein leakage within the retinal arcades by fluorescein angiography 3)Best corrected visual acuity (BCVA) of over 20/320 in ETDRS letter score 4)CRT of over 300 um as measured by the retinal map (1-mm field) of OCT
Exclusion criteria
Exclusion criteria: 1)Panretinal or macular laser photocoagulation (including grid photocoagulation) within 3 months 2)Macular ischemia involving the center of the macula that is likely to preclude improvement in BCVA 3)Vitreomacular traction evident biomicroscopically or on OCT 4)Active proliferative diabetic retinopathy (characterized by any of the following: vitreous hemorrhage, preretinal hemorrhage, disc neovascularization, retinal neovascularization, and proliferative membrane or tractional retinal detachment with neovascularization) 5)Glaucoma or optic atrophy 6)History of any vitreous surgery 7)Aphakia 8)Treatment with any drug injected into the vitreous cavity or around the eye within 3 months 9)Cataract that prevents fundus examinations required for the study 10)Cataract surgery within 3 months 11)Severe systemic conditions such as severe heart disease and cerebrovascular disorder 12)Significant renal impairment defined as a serum creatinine level of over 2.0 mg/dL or Stage 3B or greater overt nephropathy (including subjects requiring hemodialysis) 13)Uncontrolled hypertension (systolic over 180, diastolic over110 mmHg) 14)Uncontrolled diabetes mellitus (HbA1c over 10% [NGSP]) 15)Ocular inflammation including trace or above in the study eye 16)Pregnant or breast-feeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline change of MA counts and brightness assessed by FA | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Baseline change of Visual acuity by logMAR 2. Baseline change of Central Retinal thickness (CRT) by OCT 3. Electroretinography(ERG) 4. Baseline change of DRSS 5. Safety | — |
Countries
Japan
Contacts
Public ContactMasahiko Sugimoto, MD, PhD
Mie University Department of Ophthalmology
Outcome results
None listed