Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Spontaneous Retinal Arterial Pulsations (SRAPs) as a Prognostic Determinant of Central Retinal Vein Occlusions (CRVOs) in patients treated or not with intravitreal injections of aflibercept

This research is investigating an eye condition called central retinal vein occlusion (CRVO). This happens when a tiny blood vessel at the back of the eye gets blocked, which can lead to blurry vision. The study aims to see if a small, natural pulsing of blood vessels in the eye, called SRAPs, can help predict how well a treatment called aflibercept injections works. Aflibercept (also known as Eylea) is a common medication given as an injection into the eye to help improve vision for people with CRVO. Researchers will be looking at how much people's vision improves over one year and also checking other things like swelling in the eye and how often injections are needed. This could help doctors better understand who might benefit most from the treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondation A De Rothschild

Enrolment target

Start

12 Nov 2024

central retinal vein occlusions

What is this study about?

This research study is focusing on an eye condition called central retinal vein occlusion, often shortened to CRVO. This happens when one of the main veins that carries blood away from the retina (the light-sensitive layer at the back of your eye) gets blocked. This blockage can cause blood and fluid to leak into the retina, leading to swelling and blurred vision, or even vision loss.

The study is specifically looking at something called "Spontaneous Retinal Arterial Pulsations" (SRAPs). These are very subtle, natural pulses that can sometimes be seen in the blood vessels at the back of your eye. Researchers want to find out if the presence or absence of these pulses can help predict how well someone with CRVO will respond to treatment with a medication called aflibercept. Aflibercept, also known by its brand name Eylea, is a commonly used drug for CRVO. It's given as an injection into the eye and helps to reduce swelling and improve vision.

Over a year, the main thing the study will measure is how much people's vision improves. They will use a standard eye chart to check this. They will also be looking at other important aspects like how much swelling is in the retina (checked with a special eye scan called an OCT), how many injections a person needs, and if there are any other problems or complications related to their CRVO. The goal is to better understand CRVO and its treatment, which could ultimately help doctors make more informed decisions about care for their patients.

Key takeaways

The study aims to understand CRVO and how to predict treatment success.
It's looking at a natural eye pulse (SRAPs) as a potential predictor for aflibercept treatment.
Participation involves regular eye check-ups, including vision tests and eye scans (OCT).
The treatment used, aflibercept (Eylea), is a standard, approved medication.
The study lasts for about one year and involves monitoring your vision and eye health.
This research could help doctors make better decisions about CRVO treatment in the future.

Who may be eligible?

This study is open to both men and women aged 18 years and older. There is no upper age limit, so older adults can also take part.

To be considered for this study, you would need to have been diagnosed with central retinal vein occlusion (CRVO). The researchers are interested in people who are either receiving treatment with aflibercept injections or who might be starting this treatment.

It's important to remember that even if you meet these general criteria, there might be other specific health details that would mean you can or cannot join the study. Your eye doctor would be able to check all the detailed requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of central retinal vein occlusion (CRVO)?
Are you open to having regular eye check-ups and scans for a year?
Are you either receiving or likely to receive aflibercept (Eylea) injections for your CRVO?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main assessment will be how your eyesight changes over a period of one year. This will involve regular eye doctor appointments where your vision will be tested using a standard eye chart, similar to what you might do at a regular eye check-up. You'll also have special scans of your eye, called OCTs, to measure any swelling in the back of your eye.

For those receiving the treatment, the study will involve injections of aflibercept (Eylea) into your eye as determined by your eye doctor, following standard treatment practice. The researchers will keep track of how many injections you receive throughout the first year and how much time passes between these injections. They will also look at your medical records to see if you have any other complications related to your CRVO. The total duration of active participation and assessments for this study is approximately one year.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. A potential benefit of this study is that you would receive regular, detailed monitoring of your eye condition and treatment from eye specialists. You might also be contributing valuable information that could help improve care for future patients with CRVO. As for risks, you would be undergoing standard medical treatments (aflibercept injections) that carry their own known, though generally small, risks, such as infection or increased eye pressure. There are no additional experimental treatments involved. It is very important to remember that joining a study is always your choice, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is central retinal vein occlusion (CRVO)?

It's an eye condition where a blood vessel at the back of your eye gets blocked, causing fluid to leak and your vision to become blurry.

What are SRAPs?

SRAPs are very small, natural pulses that can be seen in the blood vessels in your eye. This study is looking to see if they can help predict treatment success.

What is aflibercept (Eylea)?

It's a common medicine injected into the eye to help reduce swelling and improve vision for people with certain eye conditions, including CRVO.

How long will the study last?

If you take part, your participation in the study and assessments will last for about one year.

Will I get 'new' treatment in this study?

No, this study uses a standard, approved treatment (aflibercept). It's looking at how well it works and identifying factors that might predict success.