ClinicalTrials.gg
CompletedNCT03321916Updated Mar 8, 2023

MacTel Laser Study

An interventional study of 577-nm PASCAL laser in Macular Telangiectasia, sponsored by The Lowy Medical Research Institute Limited. Completed at 1 site in United States. Open to participants aged 21 Years to 79 Years. Per ClinicalTrials.gov, last updated 2023-03-08.

Sponsored by The Lowy Medical Research Institute Limited · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Dec 2022, 3 years 10 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
21 Years to 79 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Macular Telangiectasia

Browse trials for

Keywords

  • MacTel
03

In context

Telangiectasis

69 studies on the registry are indexed under Telangiectasis; 12 are open to participants now.

This study's enrollment of 9 is below the median of 30 across 59 interventional studies indexed under Telangiectasis.

Browse Telangiectasis studies →

Lead sponsor

The Lowy Medical Research Institute Limited is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed and dated written obtained from the participant in accordance with the local regulations;
  2. Males/females 21 years of age and older but less than 80 years of age;
  3. 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;
  4. 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;
  5. Participant's best-corrected visual acuity at least 55 letters (20/80) in the study eye;
  6. 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;
  7. Participant must be able and willing to attend all scheduled visits.

    For Participants undergoing optional AOSLO imaging:

  8. 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

Exclusion Criteria:

  1. Participant is unable to provide ;
  2. Participant is less than 21 years of age or greater than 80 years of age; (but less than 80);
  3. Participant is medically unable to comply with study procedures or follow-up visits;
  4. 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;
  5. Participant has nystagmus in either eye;
  6. Participant has greater than 7 diopters myopia in either eye;
  7. Participant has been diagnosed and treated for amblyopia in the study eye;
  8. Participant has significant ocular abnormalities in either eye that prevent retinal assessment, including media opacities or cataract (up to Nuclear Sclerosis +1 is allowable);
  9. Participant was a study participant in any other clinical trial of an intervention (drug or device) within the last 6 months;
  10. Participant has a history of that would compromise the 12 month study survival; or
  11. Participant has, in the opinion of the Investigator, any physical or mental condition that would increase the patient's risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments;
  12. Presence of signs of advanced retinal/vascular disease in the study eye, such as CNV, haemorrhages or macular atrophy based on OCT or FAF;
  13. Previous macular laser treatment in either eye;
  14. Any previous ocular condition that may be associated with a risk of developing macular oedema;
  15. Vitreomacular traction determined clinically and/or by OCT, which in the opinion of the investigator contributes to the macular oedema (associated or causing a detachment of the fovea) in the study eye;
  16. Presence of other macular disease such as epiretinal membrane in the study eye;
  17. Ocular or periocular infections;
  18. Planned intra-ocular surgery in the study eye within one year; and
  19. Patient is unavailable for follow-up visits.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Subthreshold Photothermal Therapy

    Device: 577-nm PASCAL laser

  • Sham comparator
    Sham

    Device: 577-nm PASCAL laser

Interventions

  • Device577-nm PASCAL laser

    The Topcon/Endpoint Management System™ is a cleared medical device commonly used in the treatment of ocular disorders.

06

What researchers measure

Primary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    To evaluate the safety and tolerability of subthreshold photothermal therapy in patients with MacTel Type 2 as assessed by CTCAE v4.0

    Time frame: 3 months post treatment

Secondary outcomes

  1. Change from baseline cone density as measured by confocal adaptive optics (AOSLO)

    To evaluate the biological activity of subthreshold photothermal therapy in patients with MacTel Type 2.

    Time frame: 1 year

  2. Change in size of ellipsoid zone break area as measured by spectral domain optical coherence tomography (SD-OCT)

    To evaluate the biological activity of subthreshold photothermal therapy in patients with MacTel Type 2.

    Time frame: 1 year

  3. Development or extension post therapy of areas of deficiency in cones as measured by AOSLO

    To evaluate the biological activity of subthreshold photothermal therapy in patients with MacTel Type 2.

    Time frame: 1 year

07

Study locations

1 site
  • Medical College of Wisconsin & Froedtert Hospital
    Milwaukee, Wisconsin 53226, United States
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03321916
Lead sponsor
The Lowy Medical Research Institute Limited
Responsible party
Sponsor
First posted
Oct 26, 2017
Start date
Feb 8, 2018
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Mar 8, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion