Evaluation of morphological-based treatment regimen of aflibercept in patients with diabetic macular edema
Phase 4
- Conditions
- Diabetic Macular Edema
- Registration Number
- JPRN-UMIN000025490
- Lead Sponsor
- Department of Ophthalmology Tokyo Medical University, Hachioji Medical Center
- Brief Summary
Mean improvement from baseline visual acuity at 12 month was 0.17 plus/minus 0.24 logMAR (8.5 letters). Proportion of eyes gained more than 0.3 logMAR was 30.6%, and lost over 0.3 logMAR was 4.1%. Eighteen eyes (36.7%) showed prompt regression of CMT soon after the 1st aflibercept injection, while 7 eyes (14.3%) required 6 continuous injections at loading phase. Total required number of aflibercept injection averaged 7.14 plus/minus 1.08 times.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 49
Inclusion Criteria
Not provided
Exclusion Criteria
Vitrectomized eye Previous anti-VEGF therapy Previous any treatment for DME before 90 days Pregnant or potentially pregnant Uncontrolled general condition Ocular inflammation Active proliferative diabetic retinopathy
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method