Intravitreal Aflibercept for Macular Edema Due to Central Retinal Vein Occlusion

University of Athens51 enrolled

Overview

Central retinal vein occlusion (CRVO) is a common retinal vascular disorder, occurring when there is a blockage to the main blood vessel that transports blood away from the retina. CRVO may cause visual impairment, especially due to macular edema (swelling of the macula due to fluid accumulation) and macular non-perfusion. Aflibercept has been found to improve visual acuity and reduce macular thickness in pivotal trials. The purpose of this study was to evaluate the efficacy and safety of intravitreal aflibercept in real-world, using a patient-fitted treatment regimen. Additionally, imaging parameters have been assessed before and after treatment with intravitreal aflibercept.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Retinal Vein Occlusion Vascular Occlusive Disease

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Treatment naive center-involved macular edema secondary to CRVO for no longer than 3 months. * Patients \>18 years of age, who are diagnosed with macular edema secondary to CRVO who are scheduled to be treated with intravitreal aflibercept in real-life conditions * BCVA of Snellen of 20/40 to 20/200 in the study eye Exclusion Criteria: * Previous PRP or macular laser photocoagulation in the study eye. * Any prior ocular treatment in the study eye for macular edema secondary to CRVO. * Prior systemic anti-VEGF or corticosteroid therapy, within the last 3 months before enrollment to the study. * Any active or previous inflammation, ocular trauma * Uncontrolled glaucoma (IOP\>30 mmHg)

Outcomes

Primary Outcomes

Change in visual acuity as measured using ETDRS charts

Time frame: 5 years

Change in retinal thickness as measured in μm using spectral domain optical coherence tomography

Time frame: 5 years

Secondary Outcomes

Change in microvascular parameters in OCT angiography (vessel density, FAZ area)

Time frame: 2 years

Complications

Time frame: 5 years

Change in endothelial dysfunctionafter aflibercept treatment, as measured by the perfused boundary region sublingual 5-25 μm

Time frame: 6 months