Intravitreal Aflibercept for Macular Edema Due to Central Retinal Vein Occlusion

699/2019

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.

2017-01-01

2020-12-31

2024-03-31

Completed

Early phase I

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 51, 'type': 'ACTUAL'}}

2024-05-16