- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03321916
MacTel Laser Study
December 27, 2022 updated by: The Lowy Medical Research Institute Limited
Controlled Pilot Study for Safety and Efficacy of Subthreshold Photothermal Therapy for Patients With Macular Telangiectasia (MacTel) Type 2
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin & Froedtert Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
- 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.
For Participants undergoing optional AOSLO imaging:
- 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);
- Participant was a study participant in any other clinical trial of an intervention (drug or device) within the last 6 months;
- Participant has a history of malignancy that would compromise the 12 month study survival; or
- 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;
- Presence of signs of advanced retinal/vascular disease in the study eye, such as CNV, haemorrhages or macular atrophy based on OCT or FAF;
- Previous macular laser treatment in either eye;
- Any previous ocular condition that may be associated with a risk of developing macular oedema;
- 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;
- Presence of other macular disease such as epiretinal membrane in the study eye;
- Ocular or periocular infections;
- Planned intra-ocular surgery in the study eye within one year; and
- Patient is unavailable for follow-up visits.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Sham
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The Topcon/Endpoint Management System™ is a cleared medical device commonly used in the treatment of ocular disorders.
|
Experimental: Subthreshold Photothermal Therapy
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The Topcon/Endpoint Management System™ is a cleared medical device commonly used in the treatment of ocular disorders.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 3 months post treatment
|
To evaluate the safety and tolerability of subthreshold photothermal therapy in patients with MacTel Type 2 as assessed by CTCAE v4.0
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3 months post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline cone density as measured by confocal adaptive optics (AOSLO)
Time Frame: 1 year
|
To evaluate the biological activity of subthreshold photothermal therapy in patients with MacTel Type 2.
|
1 year
|
Change in size of ellipsoid zone break area as measured by spectral domain optical coherence tomography (SD-OCT)
Time Frame: 1 year
|
To evaluate the biological activity of subthreshold photothermal therapy in patients with MacTel Type 2.
|
1 year
|
Development or extension post therapy of areas of deficiency in cones as measured by AOSLO
Time Frame: 1 year
|
To evaluate the biological activity of subthreshold photothermal therapy in patients with MacTel Type 2.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 8, 2018
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
October 18, 2017
First Submitted That Met QC Criteria
October 23, 2017
First Posted (Actual)
October 26, 2017
Study Record Updates
Last Update Posted (Estimate)
December 28, 2022
Last Update Submitted That Met QC Criteria
December 27, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MacTelLaser1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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