Study of Serine Supplementation to Protect Vision in MacTel (NCT07342439) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Study of Serine Supplementation to Protect Vision in MacTel
United States, Australia, Germany120 participantsStarted 2026-09
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Be able to read, comprehend, and agree to conditions as explained in the informed consent document and provide written informed consent;
* Be at least 18 years of age;
* Enrolled or enrolling in the Natural History Observation and Registry Study (NHOR) and confirmed with MacTel type 2 by the Reading Center in at least one eye\*;
* Participant has clear ocular media (both eyes) for sufficient image quality;
* Participant must have steady fixation in the foveal or parafoveal area;
* Female participants of childbearing potential must agree to use a highly effective method of contraception from the time consent is signed until six days after treatment discontinuation (this is due to a lack of safety data on use of L-serine in pregnant and breastfeeding women; and to allow for medication wash out post treatment discontinuation). Highly effective methods of contraception include:
(i)Combined hormonal contraception associated with inhibition of ovulation, (ii) progesterone only hormonal contraception associated with inhibition of ovulation (iii) Intrauterine devices, (iv) surgical sterilization such as bilateral tubal occlusion or vasectomized partner or (v) true abstinence (refraining from heterosexual intercourse during the entire period associated with the study treatments, and the reliability of sexual abstinence is in line with the usual lifestyle of the subject)
* Willing and able to comply with study protocol and follow-up visits
* Agree to unconditio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 3 trial for MacTel, what does that mean for what's already known about the safety of serine supplementation, and is there enough evidence so far that it might actually slow my vision loss?
2The trial is measuring 'EZ loss' as its main outcome — can you explain what the ellipsoid zone is, why losing it matters for my vision, and whether my current scans show changes there that would make this relevant to my situation?
3This trial isn't recruiting yet — do you know roughly when it might open, and is it worth waiting for it, or should we be looking at other treatment options or existing trials in the meantime?
4Serine is an amino acid supplement rather than a drug injection — how does that change the day-to-day demands of being in this trial compared to other MacTel studies, and are there any known risks from taking serine at supplemental doses over time?
5Given that MacTel has limited proven treatments right now, would you recommend I pursue standard monitoring and supportive care first, or do you think a trial like this one is something worth actively planning for given the stage of my condition?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
EZ loss
Timeframe: Baseline through Month 24
Trial details
NCT IDNCT07342439
SponsorThe Lowy Medical Research Institute Limited