Macular TelangiectasiaNCT03321916
MacTel Laser Study
A study testing 577-nm PASCAL laser in people with Macular Telangiectasia, run by The Lowy Medical Research Institute Limited at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 79 years
- Conditions the study is for
- Macular Telangiectasia
- What is being tested?
- 577-nm PASCAL laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin & Froedtert Hospital
Milwaukee, Wisconsin, 53226
About this study
Official title: 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.
- Conditions
- Macular Telangiectasia
- Being tested
- 577-nm PASCAL laser
- Keywords
- MacTel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
577-nm PASCAL laserDevice
The Topcon/Endpoint Management System™ is a cleared medical device commonly used in the treatment of ocular disorders.
| Study group | Role | What they receive |
|---|---|---|
| Subthreshold Photothermal Therapy | Experimental | Not described Receives: Device: 577-nm PASCAL laser |
| Sham | Sham comparator | Not described Receives: Device: 577-nm PASCAL laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months post treatment
Secondary outcomes (3)
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start8 Feb 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular TelangiectasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Lowy Medical Research Institute Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321916
- Sponsor's protocol ID
- MacTelLaser1
- Status last verified
- Mar 2023
- First submitted
- 18 Oct 2017
- Last updated
- 8 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Pilot Study for Safety and Efficacy of Subthreshold Photothermal Therapy for Patients With Macular Telangiectasia (MacTel) Type 2
- ClinicalTrials.gov ID
- NCT03321916
- Acronym / sponsor ID
- MacTelLaser1
- Conditions
- Macular Telangiectasia
- Keywords
- MacTel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The Lowy Medical Research Institute LimitedUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subthreshold Photothermal Therapy | Experimental | Device: 577-nm PASCAL laser |
| Sham | Sham comparator | Device: 577-nm PASCAL laser |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 577-nm PASCAL laserThe Topcon/Endpoint Management System™ is a cleared medical device commonly used in the treatment of ocular disorders. | Device | Sham, Subthreshold Photothermal Therapy |
Primary outcome
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
3 secondary outcomes
Change from baseline cone density as measured by confocal adaptive optics (AOSLO)
Time frame: 1 year
Change in size of ellipsoid zone break area as measured by spectral domain optical coherence tomography (SD-OCT)
Time frame: 1 year
Development or extension post therapy of areas of deficiency in cones as measured by AOSLO
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 577-nm PASCAL laser in people with Macular Telangiectasia, run by The Lowy Medical Research Institute Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 3 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.