MacTel Laser Study (NCT03321916) | Clinical Trial Compass
CompletedNot Applicable
MacTel Laser Study
United States9 participantsStarted 2018-02-08
Plain-language summary
This is a two armed Single Masked Pilot Study enrolling participants with Macular Telangiectasia Type 2 who will be randomized to undergo either a subthreshold photothermal treatment or a sham procedure to one eye. The participants will be followed for one year with visits at 1 month, 3 months, 6 months and 12 months post-treatment (laser or sham). Due to the small number of participants enrolled in this study the data will be analyzed by descriptive statistics and exploratory figures. Summary statistics will be produced for study and fellow eyes.
Who can participate
Age range
21 Years – 79 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
. Signed and dated written informed consent obtained from the participant in accordance with the local regulations;
. Males/females 21 years of age and older but less than 80 years of age;
. Participant must have a positive diagnosis of MacTel Type 2 in at least one eye with evidence of fluorescein leakage typical of MacTel or at least one of the other features including loss of retinal transparency/hyper-reflectivity to blue light, crystalline deposits, right angle vessels, inner/outer retinal low-reflective spaces, or hyperpigmentation not involving the center of the fovea, but no evidence of intraretinal/subretinal vascular proliferation;
. Participant must have an Ellipsoid Zone (EZ, aka IS/OS) break in the study eye between 0.16 - 4.0 mm2 as measured on SD-OCT;
. Participant's best-corrected visual acuity at least 55 letters (20/80) in the study eye;
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Timeframe: 3 months post treatment
Trial details
NCT IDNCT03321916
SponsorThe Lowy Medical Research Institute Limited
. Participant must have steady fixation in the foveal or parafoveal area of each eye, adequate pupil dilation and sufficiently clear media to perform multi-modal retinal imaging and treatment;
. Participant must be able and willing to attend all scheduled visits.
. Participant should have reproducible baseline AOSLO image montages at 2 baseline imaging sessions with quality suitable to identify a minimum of 7 regions of interest (ROIs) at which reliable cone spacing measures can be made in each eye.
Exclusion criteria
. Participant is unable to provide informed consent;
. Participant is less than 21 years of age or greater than 80 years of age; (but less than 80);
. Participant is medically unable to comply with study procedures or follow-up visits;
. Participant received intravitreal therapy for non-neovascular MacTel in the study eye and in the fellow eye, injections no sooner than 3 months prior to study treatment;
. Participant has nystagmus in either eye;
. Participant has greater than 7 diopters myopia in either eye;
. Participant has been diagnosed and treated for amblyopia in the study eye;
. Participant has significant ocular abnormalities in either eye that prevent retinal assessment, including media opacities or cataract (up to Nuclear Sclerosis +1 is allowable);