This study is an interventional, prospective randomized study comparing the dexamethasone implant to intravitreal aflibercept. Subjects will have an initial single injection of aflibercept and will be randomized if diabetic macular edema persists. Each subject will be evaluated for 6 months following randomization. Thus, the study duration will be 12 months plus the recruitment period. Subjects will be evaluated every month for safety, efficacy as measured by SDOCT and best corrected visual acuity (BCVA) using the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) protocol. In addition, ultra-widefield angiography will be performed at run-in visit, baseline, month 3, and month 6.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
A sustained-release drug delivery system containing 0.7 mg of Dexamethasone. Implant is administered by intravitreal injection.
A single dose, 2mg, drug administered by intravitreal injection.
Retina Consultants of Houston
Houston, Texas, United States
The Mean Change in Central Subfield Thickness
It is defined as the mean change in the thickness between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) in the central 1mm. Discrepancy in total number relates to variable follow up for evaluation of change in parameter.
Time frame: 6 months
Number of Injections
Average number of Injections
Time frame: 6 months
Change in BCVA
Time frame: 6 months
Change in Leakage Index
Leakage index refers to the percentage of leakage measured across the region of interest which are both evaluated using an imaging software for analysis. Greater leakage represents increased disease activity. The leakage index goes from 0-100 at any timepoint, though the change parameter shown below can be negative.
Time frame: 6 months
Change in Ischemic Index
Ischemic index represents the percentage of ischemia of the region of interest in fundus fluorescein angiography images. The range is 0-100 at each timepoint assessed. All things being equal greater ischemia corresponds to more severe disease. Given this parameter is a change between time points for this index, the number can be negative.
Time frame: 6 months
Change in Microaneurysm Counts
Microaneurysms are counted on the fluorescin angiography images. It is a count so there is not a set range though the vast majority of patients tend to fall between 0 to 2000 microaneurysms. All things being equal greater count represents more severe disease.
Time frame: 6 months
Change in Ellipsoid Zone Integrity
Change in ellipsoid zone integrity as measured by EZ-RPE volume. Reduced volume indicates increased disruption to the ellipsoid zone across the macular cube scan. The range is subject to differences between timepoints.
Time frame: 6 months
Change in Intraretinal Fluid Volume
This parameter is the total intraretinal fluid measured on the OCT imaging platform across the entire macular cube scan. It is a quantitative measure of macular edema and higher volume represents worse swelling.
Time frame: 6 months
Change in DRSS
Diabetic retinopathy severity scale (DRSS) was assessed at the screening visit and the month 6 visit using color fundus photography across both the intravitreal dexamethasone implant (Group A) and the intravitreal aflibercept group (Group B). DRSS assesses disease severity by extent of diabetic involvement in the eye from microaneurysms only (low severity) to vitreous hemorrhage and/or neovascularization of the disc (high severity). The scale using the ETDRS Steps range from 1 to 12. A higher score represents more severe diabetic disease burden. Thus a more negative change in DRSS value corresponds to a better therapeutic response.
Time frame: 6 months
The Incidence and Severity of Ocular and Non-ocular Adverse Events and Serious Adverse Events
Number of adverse events.
Time frame: 6 months
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