L-serine for MacTel

(SEErine Trial)

Not yet recruiting at 11 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: The Lowy Medical Research Institute Limited

Must not be taking: Fibrates, Tamoxifen, Chloroquine, others

Disqualifiers: Pregnancy, Diabetes, Cancer, Liver disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to look at the efficacy and safety of giving oral serine (an amino acid) on the progression of structural and functional changes of the retina in people with MacTel type 2. The main questions it aims to answer are:

* Does serine slow the progression of MacTel?

* Is long-term serine supplementation safe in people with MacTel? Researchers will compare serine to a placebo (a look-alike substance that contains no drug) to see if serine works to slow the progression of MacTel.

Participants will:

* Take serine or a placebo twice a day for 24 months

* Visit the clinic once every 6 months for eye exam, eye imaging and blood tests

* Keep a diary of their symptoms, missed doses, and changes in medications

Are You a Good Fit for This Trial?

This trial is for adults with MacTel type 2 who can consent to the study, have clear vision media for imaging, and reliable contraception if applicable. They must be able to follow the protocol, fast before blood tests, and already be part of or joining the NHOR with confirmed MacTel type 2 in at least one eye.

Inclusion Criteria

I can read and understand the consent form and agree to its conditions.

I am 18 years old or older.

My eyes are clear enough for high-quality imaging.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive oral serine or placebo twice a day for 24 months

24 months

4 visits (in-person), with telephone contacts between visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 follow-up telephone contact

What Are the Treatments Tested in This Trial?

Interventions

• L-serine

Trial Overview

The trial is testing whether taking L-serine orally twice daily over two years helps slow down vision loss in people with MacTel compared to a placebo. Participants will undergo regular eye exams, imaging, blood tests and keep a diary of symptoms.

How Is the Trial Designed?

Group I: L-serine Experimental Treatment 1 Intervention

Participant receives oral L-serine

Group II: Placebo Placebo Group 1 Intervention

Participant receives placebo

Who Is Running the Clinical Trial?

The Lowy Medical Research Institute Limited

Lead Sponsor

Trials

8

Recruited

430+