Intravitreal Aflibercept for Macular Edema Due to Central Retinal Vein Occlusion

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06416241

Acronym

INTRAMED-CRVO

Enrollment

Registered

2024-05-16

Start date

2017-01-01

Completion date

2024-03-31

Last updated

2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Vein Occlusion, Vascular Occlusive Disease

Keywords

optical coherence tomography angiography, aflibercept, retinal vein occlusion, biomarkers

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.

Interventions

DRUGEYLEA 2 MG in 0.05 ML Injection

Intravitreal injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026