1. Bressler NM, Beaulieu WT, Glassman AR, et al. Persistent macular thickening following intravitreous aflibercept, bevacizumab, or ranibizumab for central-involved diabetic macular edema with vision impairment. JAMA Ophthalmol. 2018;136(3):257-269. 2. Kiss S, Liou Y, Brown J, et al. Clinical utilization of anti-vascular endothelial growth-factor agents and patient monitoring in retinal vein occlusion and diabetic macular edema. Clin Ophthalmol. 2014;8:1611-1621. 3. Brown DM, Nguyen QD, Marcus DM, et al. Long-term outcomes of ranibizumab therapy for diabetic macular edema: the 36-month results from two phase III trials. Ophthalmology. 2013;120(10):2013-2022. 4. Heier JS, Korobelnik JF, Brown DM, et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2016;123:2376-2385.
The post-hoc study analyzed eyes treated with DME therapy in the Protocol T study.
In Protocol T, patients likely had other treatments for DME before entering the protocol.
Study groups:
Objective:
Determine presence of persistent DME defined as CST < 250 μm after 24 weeks of treatment
Bressler NM, Beaulieu WT, Glassman AR, et al. Persistent macular thickening following intravitreous aflibercept, bevacizumab, or ranibizumab for central-involved diabetic macular edema with vision impairment. JAMA Ophthalmol. 2018;136(3):257-269.
This analysis used claims data from 2008–2011 from a database covering some 64 million unique patients from approximately 80 health plans across the US. This database consists primarily (about 70%) of a commercially insured population, with the remaining 30% being self-insured, on Medicaid, or Medicare managed care patients. 2,733 newly diagnosed and anti-VEGF treatment-naïve patients were identified, all of whom had a first diagnosis of DME reported within the preceding 365 days, an initial anti-VEGF injection within 12 months of initial diagnosis, and 12 months of follow up.
Kiss S, Liou Y, Brown J, et al. Clinical utilization of anti-vascular endothelial growth-factor agents and patient monitoring in retinal vein occlusion and diabetic macular edema. Clin Ophthalmol. 2014;8:1611-1621.
RISE and RIDE were methodologically identical, randomized, double-masked, multicenter, 3-year studies that were sham injection-controlled for the first 2 years.
Study arms:
Primary endpoint:
Secondary endpoints:
Inclusion criteria: DME patients ≥ 18 years old with foveal thickness ≥ 275 μm.
Exclusion criteria: Prior vitreoretinal surgery, or panretinal/macular laser surgery in the study eye, intraocular corticosteroids, or angiogenic drugs within 3 months of screening as well as uncontrolled hypertension, HbA1c > 12%, or CVA or MI within 3 months.
Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema. Ophthalmology. 2012;119:289-801.
VIVID and VISTA were similarly designed, randomized, double-masked, active-controlled, 148-week phase 3 studies.
Study arms:
Primary endpoint: Change from baseline BCVA at week 52
Inclusion criteria: Adult diabetics with DME and BCVA between 73 and 24
Letters (20/40 to 20/320)
Heier JS, Korobelnik JF, Brown DM, et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2016;123:2376.
Tel: +1 844 445 8843, Option 3
Summary Overview of AccessPlus
Tel +1 844 445 8843, Option 4
Fax: +1 678 990 5743