Intravitreal Aflibercept for Macular Edema Due to Central Retinal Vein Occlusion

Retinal Vein Occlusion Clinical Trial

— INTRAMED-CRVO  

Official title:

Intravitreal Aflibercept for Macular Edema Due to Central Retinal Vein Occlusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06416241
• Other study ID #: 699/2019
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2017
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2024
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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)

Related Conditions & MeSH terms

• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• EYLEA 2 MG in 0.05 ML Injection
Intravitreal injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in visual acuity as measured using ETDRS charts		5 years
Primary	Change in retinal thickness as measured in µm using spectral domain optical coherence tomography		5 years
Secondary	Change in microvascular parameters in OCT angiography (vessel density, FAZ area)		2 years
Secondary	Complications		5 years
Secondary	Change in endothelial dysfunctionafter aflibercept treatment, as measured by the perfused boundary region sublingual 5-25 µm		6 months