NCT02503540

Peripheral and Macular Retinal Vascular Perfusion and Leakage in DME and RVO

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Justis Ehlers · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Retinal Vein Occlusion
• Diabetic Macular Edema
• Branch Retinal Vein Occlusion
• Central Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	Aflibercept	Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.

Timeline

• Start date: 2015-08-18
• Primary completion: 2018-02-06
• Completion: 2018-02-06
• First posted: 2015-07-21
• Last updated: 2021-05-12
• Results posted: 2020-02-12

Locations

1 site across 1 country: United States