Intravitreal Aflibercept for Macular Edema Due to Central Retinal Vein Occlusion

Phase 4

Completed

• Conditions: Retinal Vein Occlusion; Vascular Occlusive Disease
• Interventions: Drug: EYLEA 2 MG in 0.05 ML Injection

• Registration Number: NCT06416241
• Lead Sponsor: University of Athens

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2024-03-31
• Status Verified: 2024-05
• Study First Submitted: 2024-05-08
• Study First Submitted QC: 2024-05-10
• Last Update Submitted: 2024-05-10
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eylea 2.0mg/0.05ml	EYLEA 2 MG in 0.05 ML Injection	-

Primary Outcome Measures

Name	Time	Method
Change in retinal thickness as measured in μm using spectral domain optical coherence tomography	5 years
Change in visual acuity as measured using ETDRS charts	5 years

Secondary Outcome Measures

Name	Time	Method
Change in microvascular parameters in OCT angiography (vessel density, FAZ area)	2 years
Complications	5 years
Change in endothelial dysfunctionafter aflibercept treatment, as measured by the perfused boundary region sublingual 5-25 μm	6 months