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

National and Kapodistrian University of Athens

Status and phase

Completed

Phase 4

Conditions

Vascular Occlusive Disease

Retinal Vein Occlusion

Treatments

Drug: EYLEA 2 MG in 0.05 ML Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT06416241

699/2019

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

18 to 95 years old

Volunteers

Accepts Healthy Volunteers

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)