This interventional study will evaluate the retinal vascular dynamics associated with Intravitreal Aflibercept Injection (IAI) therapy in eyes with diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion (RVO). Ultra-widefield fluorescein angiography and optical coherence tomography (OCT) angiography will be performed at multiple timepoints to assess the changes in retinal vascular leakage, ischemia, and vascular abnormalities throughout the study duration and compare these alterations to baseline.
Diabetic macular edema (DME) and macular edema secondary to retinal venous occlusive diseases are the most common cause of vision loss from a retinal vascular disease. Recently, vascular endothelial growth factor (VEGF) inhibitors (bevacizumab, aflibercept, and ranibizumab) have been described as new first-line therapies for these conditions. Aflibercept is the most recently approved VEGF inhibitor for the management of these conditions. Clinical trials have shown that treatment with aflibercept improves visual acuity and reduces macular edema in a large percentage of patients. This study will examine the changes that occur with intravitreal aflibercept to perfusion and leakage in treatment naive eyes over the course of 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Cole Eye Institute, Cleveland Clinic
Cleveland, Ohio, United States
Change in Panretinal Leakage Index at Month 12 From Baseline
Change in panretinal leakage index (defined as the proportion of retinal area involved in angiographic leakage) at month 12 from baseline as measured by ultra-widefield angiography (UWFA).
Time frame: 12 months
Mean Change in Total Leakage Index
Mean change in total leakage index from baseline to month 6
Time frame: 6 months
Change in Panretinal Ischemic Index
Change in panretinal ischemic index from baseline to postoperative month 12
Time frame: 12 months
Change in Panretinal Ischemic Index From Baseline at 6 Months
Change in panretinal ischemic index (defined as the proportion of retinal area with nonperfusion) from baseline at 6 months
Time frame: 6 months
Mean Change From Baseline Central Subfield Thickness
OCT central subfield thickness change from baseline to 6 months
Time frame: 6 months
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) Score Based on ETDRS
Mean change from baseline in best-corrected visual acuity (BCVA) score from baseline to month 12
Time frame: 12 months
Number of Participants Who Gained 15 ETDRS Letters or More of Vision
Time frame: 12 months
Number of Patients Who Gained 15 ETDRS Letters or More of Vision
Time frame: 6 months
Number of Patients That Showed Visual Acuity 20/40 or Better
Time frame: 6 months
Number of Patients That Showed Visual Acuity 20/200 or Worse
Time frame: 6 months
Ocular Serious Adverse Events
Time frame: 12 months
Number of Participants Who Lost 15 ETDRS Letters or More of Vision
Time frame: 12 months
Number of Participants Who Lost 15 ETDRS Letters or More of Vision
Time frame: 6 months
Number of Patients That Showed Visual Acuity 20/40 or Better
Time frame: 12 months
Number of Patients That Showed Visual Acuity 20/200 or Worse
Time frame: 12 months
Mean Change From Baseline Central Subfield Thickness
Time frame: 12 months
Systemic Serious Adverse Events
Incidence of systemic SAEs
Time frame: 12 Months
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