Diabetic macular edema
Conditions
Interventions
anti-VEGF monotherapy
anti-VEGF therapy and End-Point-Management (EPM) grid laser photocoagulation
Sponsors
University of Hong Kong, Nagoya City University Graduate school of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible, the following inclusion criteria must be met: Age; 18 years with CSME Diagnosis of diabetes mellitus (type 1 or type 2) At least one eye meets the study eye criteria Able and willing to provide informed consent prior to any study-related procedures Central foveal thickness; 300 microns at baseline (SPECTRALIS or Cirrus HD OCT) LogMAR Best corrected visual acuity 0.30 (Snellen 20/25) to 1.3 (Snellen 20/400). Willing and able to comply with clinic visits and study-related procedures Central Foveal Thickness on OCT 300-600 micron After first injection, wait for ME to reduce before proceeding with the laser. Exclude if ME persists >500um at the 4-week follow up
Exclusion criteria
Exclusion criteria: Macular edema is considered to be due to a cause other than diabetic macular edema. An ocular condition is present such that visual acuity loss would not improve from resolution of macular edema. Substantial cataract that is likely to be affecting visual acuity. Focal laser photocoagulation should be performed before enrolling into the study if needed. Three months gap required between last laser procedure and recruitment. History of panretinal (scatter) photocoagulation (PRP) within 3 months prior to enrollment. Anticipated need for PRP in the study period. History of major retinal surgery. History of YAG capsulotomy performed within 3 months. Aphakia. History of open-angle glaucoma. Exam evidence of external ocular infection. A subject is not eligible if any of the following exclusion criteria are present Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. A condition that would preclude participation in the study. Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months. Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization. pregnant or lactating or intending to become pregnant within the next 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in number of Anti-VEGF injections required among the two treatment arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in BCVA and OCT. Time required achieving treatment success. BCVA and OCT outcome depending on the type of DME on presentation. | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactMiho Nozaki
Nagoya City University Graduate School of Medical Sciences Ophthalmology
Outcome results
None listed