Intravitreal Aflibercept for Macular Edema Due to Central Retinal Vein Occlusion

NCT ID: NCT06416241

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2024-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinal Vein Occlusion Vascular Occlusive Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Eylea 2.0mg/0.05ml

Group Type OTHER

EYLEA 2 MG in 0.05 ML Injection

Intervention Type DRUG

Intravitreal injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EYLEA 2 MG in 0.05 ML Injection

Intravitreal injection

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Athens

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Irini Chatziralli

Associate Professor in Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

699/2019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Minocycline to Treat Central Retinal Vein Occlusion
NCT01468844 COMPLETED PHASE1/PHASE2
Minocycline to Treat Branch Retinal Vein Occlusion
NCT01468831 COMPLETED PHASE1/PHASE2