Serine and Fenofibrate Study in Patients With MacTel Type 2
This study is exploring potential treatments for Macular Telangiectasia Type 2, also known as MacTel. MacTel is an eye condition that affects vision. The research, called a Phase 2 trial, is testing two different substances: Serine and a medication called Fenofibrate, either alone or in combination. Scientists want to see if these treatments can lower specific fat-like substances in the blood (called deoxysphingolipids) which are thought to be linked to MacTel. Participants will be divided into six groups, receiving different doses of Serine, Fenofibrate, both, or no treatment. The study will last for 10 weeks, with several check-up visits, and will also look at the safety of these treatments.
At a glance
What is this study about?
This research study is about an eye condition called Macular Telangiectasia Type 2, often shortened to MacTel. This condition affects your central vision, which is what you use for seeing details clearly, like when you read. Currently, there isn't a widely effective treatment for MacTel, so doctors and scientists are constantly looking for new ways to help.
This particular study is focusing on two substances: Serine, which is a natural building block in your body, and Fenofibrate, a medicine already used to lower certain types of fats in the blood. The idea is that these substances might help reduce levels of fats in your blood called 'deoxysphingolipids', which some research suggests play a role in MacTel. By lowering these levels, scientists hope to slow down or even improve the condition.
This is a 'Phase 2' study, which means it’s still in the earlier stages. It's designed to see if these treatments are safe and if they have a positive effect on the body's chemistry in people with MacTel. The results from this study will help us understand if Serine and Fenofibrate could be promising treatments for MacTel in the future, and pave the way for bigger studies if they show good results.
Key takeaways
- This study is looking for new treatments for MacTel Type 2.
- It's testing two substances: Serine and Fenofibrate.
- The study lasts 10 weeks with several clinic visits.
- Your participation helps doctors learn more about MacTel.
- You can stop participating at any time.
Who may be eligible?
To be part of this study, you need to be at least 21 years old and able to speak English. You must already have been diagnosed with MacTel Type 2 in at least one eye and be part of another study called the Natural History Observation and Registry Study (NHOR).
There are also some reasons why you might not be able to join. For example, if you've recently taken Serine or similar supplements, or certain cholesterol-lowering medicines like fenofibrate in the last year. You also can't join if you have serious liver or kidney problems, certain blood conditions, a history of gallbladder issues, or some types of cancer within the last five years. It's important that you also haven't had an allergic reaction to Serine or fenofibrate in the past. Your doctors will check all these details carefully.
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 21 years old or older?
- Do you speak English?
- Have you been diagnosed with MacTel Type 2?
- Are you willing to come for regular clinic visits for 10 weeks?
- Have you avoided Serine or similar supplements recently?
- Are you generally in good health without major liver or kidney problems?
What does participation involve?
If you decide to take part in this study, you'll first have a screening visit to make sure you're suitable. Once you're in, you will be randomly assigned to one of six groups. This means you might receive a low dose of Serine, a high dose of Serine, Fenofibrate, a combination of Serine and Fenofibrate, or a group that doesn't receive Serine or Fenofibrate (a 'control' group).
You'll need to visit the clinic on several occasions: at the start (Week 0), and then again at Weeks 3, 6, and 10 – so five visits in total over a 10-week period. At these visits, you can expect to have blood tests after fasting (which means not eating for a certain time beforehand) and some samples taken to study your gut bacteria (microbiome samples). You'll be taking the study medication or no medication for the duration of the 10 weeks, and the team will monitor your health closely.
Potential risks and benefits
Locations (9)
- Emory UniversityVerified postcodeAtlanta, United States
- Kellogg Eye Center, University of MichiganVerified postcodeAnn Arbor, United States
- Retina Associates of ClevelandVerified postcodeCleveland, United States
- Southeastern Retina AssociatesVerified postcodeKnoxville, United States
- Retina Consultants of TexasVerified postcodeBellaire, United States
- Moran Eye Center, University of UtahVerified postcodeSalt Lake City, United States
- University of WashingtonVerified postcodeSeattle, United States
- The Eye Institute, Medical College of WisconsinVerified postcodeMilwaukee, United States
- Moorfields Eye HospitalVerified postcodeLondon, United Kingdom
Common questions
What is MacTel Type 2?
MacTel Type 2 is an eye condition that affects the central part of your vision, making it harder to see details clearly.
What are Serine and Fenofibrate?
Serine is a natural substance found in your body, and Fenofibrate is a medicine used to help lower certain fats in the blood.
How long will the study last?
The study will last for 10 weeks, with several visits to the clinic during that time.
Will I know which treatment I'm getting?
You will be randomly assigned to one of six groups, which could include different doses of Serine, Fenofibrate, a combination, or no specific study treatment, so you might not know which specific one you are getting.
What kind of tests will I have?
You'll have fasting blood tests and samples taken to study your gut bacteria at different visits.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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