Anti-VEGF monotherapy versus combined anti-VEGF and end-point-management grid laser photocoagulation for diabetic macular edema
- Conditions
- Diabetic macular edema
- Registration Number
- JPRN-UMIN000017818
- Lead Sponsor
- niversity of Hong Kong, Nagoya City University Graduate school of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in number of Anti-VEGF injections required among the two treatment arms.
- Secondary Outcome Measures
Name Time Method Change from baseline in BCVA and OCT. Time required achieving treatment success. BCVA and OCT outcome depending on the type of DME on presentation.