Efficacy and Safety of Aflibercept as Mono-therapy in Treat and Extend Regimen for DME Patients in Taiwan
- Sponsor
- Taipei Veterans General Hospital, Taiwan
- Study ID
- NCT04288232
- Phase
- PHASE3
- Status
- Completed
Conditions
- Center-involved Diabetic Macular Edema
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Aflibercept Injection [Eylea] — DRUGIntravitreal aflibercept Injection 2.0mg/0.05 ml
Study Details
Phase IIIb, multicenter, open-label, prospective, interventional study to assess the potential benefit of Aflibercept treatment administered IVT at a dosage of 2 mg with five monthly loading doses and then treat and extend over 48 weeks, with the primary endpoint as BCVA assessed at Week 52.
Key Dates
- Start date
- Aug 31, 2015
- Status verified
- Feb 2020
- Primary completion
- Nov 16, 2017
- Completion
- Nov 16, 2017
Study Design
- Enrollment
- 45 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Intravitreal afliberceptIntravitreal injection of aflibercept 2.0mg/0.05 ml Aflibercept was administered with 5 monthly loadings followed by treat-and-extend with a 4-week interval increment/decrement with maxima cap at 12 weeks to visual/anatomic stability.
Primary Outcome Measure
Mean change of best corrected visual acuity (BCVA) from baseline to week 52 [ Time Frame: baseline to week 52 ]