Intravitreal Aflibercept for Macular Edema Due to Central Retinal Vein Occlusion

NCT06416241 | Completed Phase 4 FDA Drug

• 1 other identifier: 699/2019
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Retinal Vein Occlusion; Vascular Occlusive Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (1)

Eylea 2.0mg/0.05ml

OTHER

Drug: EYLEA 2 MG in 0.05 ML Injection

Interventions

EYLEA 2 MG in 0.05 ML Injection DRUG

Intravitreal injection

Eylea 2.0mg/0.05ml

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Athens: lead

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

aflibercept; Injections

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Ophthalmology

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 16, 2024
• Study Start: January 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05