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Study on the Effect of Aflibercept Injections in Patients with Central Retinal Vein Occlusion (CRVO) and Spontaneous Retinal Arterial Pulsations (SRAPs)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on a condition called central retinal vein occlusion (CRVO), which affects the blood flow in the eye and can lead to vision problems. The study is investigating the use of a treatment called aflibercept, which is administered as an injection into the eye. Aflibercept is also known by other names, such as BAY 86-5321 and VEGF TRAP. The purpose of the study is to understand how the presence of spontaneous retinal arterial pulsations (SRAPs) can predict the outcome of CRVO in patients who receive aflibercept injections compared to those who do not.

Participants in the study will be monitored over a period of one year. During this time, their vision will be assessed to see how it changes from the beginning of the study to the end. The study will also track the number of aflibercept injections each participant receives and any changes in the thickness of the macula, which is a part of the eye that can swell in CRVO. This swelling is known as macular edema and will be evaluated by an eye specialist using a special imaging technique called OCT, which stands for optical coherence tomography.

The study aims to gather information on how effective aflibercept is in improving vision and managing symptoms in patients with CRVO. By comparing patients with and without SRAPs, researchers hope to better understand the role these pulsations play in the progression of the disease and the effectiveness of the treatment. This information could help improve treatment strategies for people with CRVO in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the patient is over 18, has a diagnosis of central retinal vein occlusion (CRVO), and has not previously received intravitreal injections or corticosteroid implants.
The patient must have experienced symptoms within the last 30 days and must be a member or beneficiary of a health insurance scheme. Women of childbearing age must commit to using effective contraception during treatment and for at least 3 months after the last injection.
Step 2
Consent and information
The patient receives detailed information about the study and signs a consent form to participate.
Step 3
Treatment initiation
The patient begins treatment with aflibercept, administered as an intravitreal injection. The medication is provided as a 40 mg/mL solution for injection in a pre-filled syringe.
Step 4
Follow-up visits
Regular follow-up visits are scheduled to monitor the patient's progress. These visits include assessments of visual acuity and macular thickness using OCT (optical coherence tomography) technology.
The number of aflibercept injections received during the first year is recorded, along with the time between the last two injections.
Step 5
One-year evaluation
At the one-year mark, a comprehensive evaluation is conducted to assess changes in visual acuity and any complications related to CRVO.
The primary goal is to measure the change in visual acuity using the ETDRS scale, which evaluates the number of letters read correctly.

Who can join the trial?

7 criteria

Patient must be over 18 years old.
Patient must have a diagnosis of CRVO (central retinal vein occlusion), which is a blockage in the main vein of the eye, with or without macular edema, which is swelling in the central part of the retina.
Patient must not have had any previous treatments with injections into the eye or with corticosteroid implants, which are medications placed inside the eye.
Patient must be a member or beneficiary of a health insurance plan.
Patient must have received information about the study and signed a consent form agreeing to participate.
For women who can have children: they must agree to use effective birth control during the treatment with aflibercept, a medication used in the study, and for at least 3 months after the last injection.
Symptoms must have started within the last month, with a maximum of 30 days before joining the study.

Who cannot join the trial?

9 criteria

Patients with other eye diseases that could affect the study results.
Patients who have had eye surgery in the last three months.
Patients with uncontrolled high blood pressure.
Patients with a history of severe allergic reactions.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial.
Patients with a history of drug or alcohol abuse.
Patients with serious medical conditions that could interfere with the study.
Patients who cannot follow the study procedures or attend all visits.

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Fondation A De Rothschild
Paris, France

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Investigated drugs

Aflibercept is a medication used in this clinical trial. It is administered through injections into the eye. Aflibercept works by blocking a protein that can cause abnormal blood vessels to grow in the eye, which can lead to vision problems. In this trial, it is being used to treat patients with central retinal vein occlusions (CRVOs) to help improve or stabilize their vision.

Aflibercept

What is already known about the treatment

Aflibercept – Aflibercept is administered through intravitreal injections, meaning it is injected directly into the eye. It is currently used in medical practice and literature for treating various eye conditions, including central retinal vein occlusions (CRVO). The main therapeutic indication for aflibercept is to improve visual acuity in patients with CRVO. At the molecular level, aflibercept works by inhibiting vascular endothelial growth factor (VEGF), which reduces abnormal blood vessel growth and leakage in the eye. It is classified pharmacologically as an anti-VEGF agent.

Investigated diseases

Central Retinal Vein Occlusion – Central Retinal Vein Occlusion (CRVO) is a condition where the main vein in the retina becomes blocked, leading to a sudden decrease in vision. This blockage causes blood and fluid to leak into the retina, resulting in swelling and impaired vision. Over time, the lack of proper blood flow can lead to the development of new, abnormal blood vessels, which may further complicate the condition. Patients may experience symptoms such as blurred vision or a sudden loss of vision in one eye. The progression of CRVO can vary, with some individuals experiencing gradual improvement, while others may have persistent vision problems. Regular monitoring by an eye specialist is essential to manage the condition effectively.