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Not yet recruitingPHASE3INTERVENTIONAL

Study of Serine Supplementation to Protect Vision in MacTel

This research study is looking into a natural supplement called L-serine to see if it can help protect the vision of people with Macular Telangiectasia Type 2, or MacTel. MacTel is an eye condition that gradually affects your central vision. The study wants to find out if taking L-serine can slow down how the disease progresses and if it's safe to take over a longer period. Participants will be given either L-serine or a placebo (a pill with no medicine) twice a day for two years. They will also have regular eye exams, imaging, and blood tests every six months to monitor their eye health and general well-being. This will help doctors understand if L-serine could be a helpful treatment for MacTel.

At a glance

Status
Not yet recruiting
Phase
PHASE3
Sponsor
The Lowy Medical Research Institute Limited
Enrolment target
120
Start
01 Sep 2026
Estimated completion
01 Feb 2030

What is this study about?

Macular Telangiectasia Type 2, often called MacTel, is an eye condition that slowly causes central vision to worsen. It happens because of changes in the light-sensing cells at the back of your eye, called the retina.

Researchers have found that changes in how the body uses a natural substance called serine might be linked to MacTel. When serine metabolism is affected, it can lead to the build-up of certain toxic substances in the eye. This study is exploring whether taking L-serine supplements could help correct this problem and reduce the potential harm to your vision.

This study will compare L-serine to a placebo (a 'dummy' pill that looks the same but contains no active ingredient). Neither you nor the study team will know if you're taking the L-serine or the placebo, which helps ensure the results are unbiased. The main goal is to see if L-serine can slow down the progression of MacTel, meaning the changes in your eyes and vision, and to check that it's safe for people with MacTel to take for a long time.

Key takeaways

  • Investigating if L-serine, a natural supplement, can protect vision.
  • Specifically for people with Macular Telangiectasia Type 2 (MacTel).
  • Compares L-serine to a placebo (dummy pill).
  • Involves taking pills twice daily for two years.
  • Requires regular eye exams, imaging, and blood tests.
  • Aims to understand safety and effectiveness in slowing MacTel progression.

Who may be eligible?

This study is looking for adults aged 18 or over who have been diagnosed with MacTel Type 2. You would need to have had your diagnosis confirmed by a specialist eye centre, often as part of another study called the Natural History Observation and Registry Study (NHOR).

To be suitable, your eyes need to be clear enough for doctors to get good quality images, and you should be able to focus your eyes steadily. Your vision in at least one eye should be good enough for doctors to measure effectively, which would be explained to you in detail.

If you are a woman who could become pregnant, you will need to agree to use a very reliable method of contraception throughout the study and for a short time afterwards. This is because we don't yet know if L-serine is safe during pregnancy or breastfeeding.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with MacTel Type 2?
  3. Can you provide written consent to participate?
  4. Are your eyes clear enough for doctors to take good quality images?
  5. If you are a woman who could become pregnant, are you able to use a highly effective form of birth control throughout the study?
Answer every question to see your result.

What does participation involve?

If you join the study, you'll be asked to take either L-serine or a placebo pill twice a day for 24 months (two years). You won't know which one you're taking, and neither will your study doctor.

Throughout the two years, you'll have clinic visits every six months. During these visits, you'll have thorough eye exams, special photographs of your eyes, and blood tests. You'll also be asked to keep a simple diary at home. This diary will help you record any symptoms you experience, if you miss any doses of your study medication, or if there are any changes to your other medications. There will also be phone calls in between visits to check on how you're doing and if you've had any side effects. After the two years of taking the medication, there will be a follow-up period to see how you are doing.

Potential risks and benefits

Participating in this study might offer the potential benefit of slowing down MacTel progression if L-serine proves to be effective. You will also receive regular and thorough eye examinations, which can be reassuring. As with any medication, there's always a possibility of side effects, and these will be carefully monitored throughout the study. We don't yet know if L-serine is safe for pregnant or breastfeeding women. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (12)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Hamilton Glaucoma Center- UCSD
    Verified postcode
    La Jolla, United States
  • University of Michigan, Kellogg Eye Center
    Verified postcode
    Ann Arbor, United States
  • Retina Associates Of Cleveland, Inc.
    Verified postcode
    Cleveland, United States
  • University of Utah Health Care, Moran Eye Center
    Verified postcode
    Salt Lake City, United States
  • Save Sight Institute
    Verified postcode
    Sydney, Australia
  • Cerulea- RVEEH
    Verified postcode
    Melbourne, Australia
  • University of Bonn
    Verified postcode
    Bonn, Germany
  • University of Freiburg, Department of Ophthalmology
    Verified postcode
    Freiburg im Breisgau, Germany
  • St. Franziskus Hospital
    Verified postcode
    Münster, Germany
  • Radboud University Medical Center
    Verified postcode
    Nijmegen, Netherlands
  • Moorfields Eye Hospital
    Verified postcode
    London, United Kingdom
  • Oxford Eye Hospital
    Verified postcode
    Oxford, United Kingdom

Common questions

What is MacTel?

MacTel (Macular Telangiectasia Type 2) is a rare eye condition that affects the macula, the part of your eye responsible for sharp, central vision, leading to a gradual decline in sight.

What is L-serine?

L-serine is a natural amino acid, a type of building block for proteins, that your body uses for many important functions. It's also available as a dietary supplement.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks exactly like the study medication but contains no active drug. It helps researchers compare the real treatment's effects fairly.

How long will the study last?

You would be taking the study medication for two years, and there will be regular check-ups during this time and afterwards.

Will I know if I'm getting the active treatment?

No, this is a 'double-masked' study, meaning neither you nor your study doctor will know if you're receiving L-serine or the placebo until the study is over.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Study of Serine Supplementation to Protect Vision in MacTel…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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