Efficacy of Treat-and-extend regimen (TER) using aflibercept in diabetic macular edema (DME) will be evaluated.
Efficacy of aflibercept for diabetic macular edema was demonstrated in the phase III, VIVID and VISTA studies. In these studies, aflibercept was injected using the fixed dosing regimen that an intravitreal injection was performed 5 times every 4 weeks and then every 8 weeks. Although the efficacy was comparable to that of ranibizumab injected every 4 weeks, continuous visits and treatments account for quite a burden. TER is regarded as a alternative regimen that may reduce visit and treatment numbers for age-related macular degeneration. TER is a variable dosing regimen that an injection interval is adjusted based on the treatment response. The aim of this study is to evaluate efficacy of TER using aflibercept for DME, by assessing changes of visual acuity at 104 weeks compared to baseline.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Aflibercept 2mg is injected into the vitreous cavity through the pars plana using 30 gauge needle-attached syringe.
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, South Korea
Gospel Hospital
Busan, South Korea
Pusan National University Hospital
Busan, South Korea
Haeundae Paik Hospital
Busan, South Korea
Changes in visual acuity from baseline to 104 weeks
Visual acuity is assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Visual acuity of 85 letters is equivalent to 20/20. Higher scores represents better functioning.
Time frame: baseline and 104 weeks
Changes in visual acuity from baseline to 52 weeks
Visual acuity is assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Visual acuity of 85 letters is equivalent to 20/20. Higher scores represents better functioning.
Time frame: baseline and 52 weeks
Changes in CSMT from baseline to 104 weeks
CSMT is central 1mm thickness of the macula measured using spectral-domain optical coherence tomography (OCT). Normal thickness is around 250μm. Increased CSMT is regarded as presence of macular edema.
Time frame: baseline and 104 weeks
Number of injections for 52 and 104 weeks
How many injections are performed from baseline to 52 and 104 weeks.
Time frame: 52 and 104 weeks
Injection interval
The interval is calculated for the next visit based on the treatment response. The range is between 4 and 12 weeks.
Time frame: 52 and 104 weeks.
Percentage of patients with injection interval of 12 weeks or more
Patients whose injection interval is extended to 12 weeks more include the patients that the next visit was calculated as 12 weeks and those that the injection was deferred in the previous visit.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Busan Paik Hospital
Busan, South Korea
Yeungnam University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Time frame: 104 weeks.
Percentage of patients that visual acuity increased 15 letters or more
Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. Percentage of patients whose visual acuity increased 15 letters or more compared to baseline will be calculated.
Time frame: baseline, 52 and 104 weeks.
Percentage of Patients With Visual Acuity >=20/40
Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. Percentage of patients with visual acuity 70 ETDRS letters (equivalent to 20/40) or better was calculated.
Time frame: 52 and 104 weeks