Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

TELeMAC - Comparative multicenter randomized study of aflibercept versus placebo in macular telangiectasia type 1

This research study, called TELeMAC, is investigating an eye medicine called aflibercept (commonly known as Eylea) for people with a rare eye problem called macular telangiectasia type 1. This condition can cause swelling in the part of the eye responsible for sharp central vision. The study compares aflibercept to a placebo, which is a dummy treatment, to see if it helps reduce this swelling. Researchers will be carefully measuring changes in the thickness of the retina (the light-sensing tissue at the back of your eye) over six months. They will also check if vision improves and look at the tiny blood vessels in the eye. The main goal is to find out if aflibercept is a safe and effective treatment for this condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire De Dijon

Enrolment target

Start

28 May 2024

macular telangiectasia type 1

What is this study about?

This study, called TELeMAC, is exploring a potential new treatment for a rare eye condition known as macular telangiectasia type 1. In this condition, the central part of your retina – the light-sensitive layer at the back of your eye that helps you see clearly – can become swollen. This swelling can affect your sharp central vision, which is important for tasks like reading or recognising faces.

The research is focused on a medicine called aflibercept, which you might know as Eylea. This drug is already used for other eye conditions that involve swelling or abnormal blood vessel growth. In this study, some participants will receive aflibercept, while others will receive a placebo, which is a dummy treatment with no active medicine. This allows researchers to fairly compare the effects of the actual medicine against no treatment to truly understand its benefits.

The main thing researchers want to find out is whether aflibercept can reduce the swelling in the retina. They will be using special eye scans to measure this very precisely over six months. They'll also be looking at how people's vision changes, examining the tiny blood vessels in the eye, and keeping a close eye on any side effects. This kind of research is really important because it helps doctors find the best ways to treat conditions like macular telangiectasia type 1 and improve the lives of people living with it.

Key takeaways

Investigating Eylea for a rare eye condition called macular telangiectasia type 1.
Compares Eylea against a dummy treatment (placebo) to see if it reduces eye swelling.
Study lasts for six months and involves regular eye injections and check-ups.
Aims to improve understanding and treatment options for this condition.
For adults aged 18 and over, diagnosed with macular telangiectasia type 1.

Who may be eligible?

To be able to join this study, you need to be an adult, 18 years of age or older. Both men and women are welcome to take part.

The study is specifically for people who have been diagnosed with macular telangiectasia type 1. There will be other specific medical checks to make sure the study is right and safe for you, but these are the very first requirements.

It's important that you discuss your interest with your eye doctor, as they will be able to tell you if you fit the full list of requirements to be considered for this research.

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?
Have you been diagnosed with macular telangiectasia type 1?
Are you able to attend regular clinic appointments for six months?
Are you comfortable with eye injections as part of treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be involved for a total of six months. Throughout this time, you would have regular visits to the clinic. At these visits, you would receive either the study medicine (aflibercept) or a dummy treatment (placebo) as an injection into your eye. You wouldn't know which one you are receiving.

At each visit, you would have detailed eye examinations, including special scans and vision tests, to see how your condition is changing. There would also be checks to make sure you are safe and well. The healthcare team will explain exactly what each visit involves and how often you would need to attend.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit if the treatment works for your condition, as it could reduce eye swelling and potentially improve your vision. However, there's also the chance you might receive the dummy treatment, which has no active medicine. Like all medicines, aflibercept can have side effects, including eye-related issues such as increased eye pressure, inflammation, or, very rarely, more serious problems like infection or retinal detachment. The research team will monitor you closely for any issues. Please remember, you are free to leave 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 macular telangiectasia type 1?

It's a rare eye condition where the central part of your retina, important for sharp vision, becomes swollen and has abnormal blood vessels.

What is aflibercept (Eylea)?

It's a medicine given as an injection into the eye, already used for some other eye conditions to help reduce swelling and abnormal blood vessel growth.

What does 'placebo' mean in a study?

A placebo is a 'dummy' treatment that looks like the real medicine but contains no active ingredients. It helps researchers see if the actual medicine really works.

How long will I be in the study?

If you join the study, you would be involved for six months, with regular clinic visits during that time.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor the study doctors will know whether you are receiving aflibercept or the placebo during the main part of the study. This helps ensure fair results.