Intravitreal Aflibercept for Macular Edema Due to Central Retinal Vein Occlusion (INTRAMED-CRVO)

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 Overview

• Status: Completed
• Conditions: Retinal Vein Occlusion; Vascular Occlusive Disease
• Intervention / Treatment: Drug: EYLEA 2 MG in 0.05 ML Injection

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Eylea 2.0mg/0.05ml	Drug: EYLEA 2 MG in 0.05 ML Injection; Intravitreal injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: biomarkers; retinal vein occlusion; aflibercept; optical coherence tomography angiography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Macular Degeneration; Macular Edema; Retinal Vein Occlusion
• Other Study ID Numbers: 699/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes