Peripheral and Macular Retinal Vascular Perfusion and Leakage Dynamics in Diabetic Macular Edema and Retinal Venous Occlusions During Intravitreal Aflibercept Injection (IAI) Treatment for Retinal Edema: PERMEATE Study
Overview
- Phase
- Phase 4
- Intervention
- Aflibercept
- Conditions
- Retinal Vein Occlusion
- Sponsor
- Justis Ehlers
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Change in Panretinal Leakage Index at Month 12 From Baseline
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Justis Ehlers
Assistant Professor of Ophthalmology
The Cleveland Clinic
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Aflibercept
Monthly aflibercept for 6 months and then every other month for 6 months.
Intervention: Aflibercept
Outcomes
Primary Outcomes
Change in Panretinal Leakage Index at Month 12 From Baseline
Time Frame: 12 months
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).
Secondary Outcomes
- Mean Change in Total Leakage Index(6 months)
- Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) Score Based on ETDRS(12 months)
- Change in Panretinal Ischemic Index(12 months)
- Number of Patients That Showed Visual Acuity 20/40 or Better(12 months)
- Number of Patients That Showed Visual Acuity 20/200 or Worse(12 months)
- Number of Patients Who Gained 15 ETDRS Letters or More of Vision(6 months)
- Ocular Serious Adverse Events(12 months)
- Change in Panretinal Ischemic Index From Baseline at 6 Months(6 months)
- Mean Change From Baseline Central Subfield Thickness(12 months)
- Number of Participants Who Gained 15 ETDRS Letters or More of Vision(12 months)
- Number of Participants Who Lost 15 ETDRS Letters or More of Vision(6 months)
- Systemic Serious Adverse Events(12 Months)