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MacTel Laser Study

Primary Purpose

Macular Telangiectasia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
577-nm PASCAL laser
Sponsored by
The Lowy Medical Research Institute Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Telangiectasia focused on measuring MacTel

Eligibility Criteria

21 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed and dated written informed consent 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:

  1. Participant is unable to provide informed consent;
  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 malignancy 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.

Sites / Locations

  • Medical College of Wisconsin & Froedtert Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Subthreshold Photothermal Therapy

Sham

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 18, 2017
Last Updated
March 7, 2023
Sponsor
The Lowy Medical Research Institute Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03321916
Brief Title
MacTel Laser Study
Official Title
Controlled Pilot Study for Safety and Efficacy of Subthreshold Photothermal Therapy for Patients With Macular Telangiectasia (MacTel) Type 2
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Lowy Medical Research Institute Limited

4. Oversight

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

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Telangiectasia
Keywords
MacTel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subthreshold Photothermal Therapy
Arm Type
Experimental
Arm Title
Sham
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
577-nm PASCAL laser
Intervention Description
The Topcon/Endpoint Management System™ is a cleared medical device commonly used in the treatment of ocular disorders.
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
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 Outcome Measure Information:
Title
Change from baseline cone density as measured by confocal adaptive optics (AOSLO)
Description
To evaluate the biological activity of subthreshold photothermal therapy in patients with MacTel Type 2.
Time Frame
1 year
Title
Change in size of ellipsoid zone break area as measured by spectral domain optical coherence tomography (SD-OCT)
Description
To evaluate the biological activity of subthreshold photothermal therapy in patients with MacTel Type 2.
Time Frame
1 year
Title
Development or extension post therapy of areas of deficiency in cones as measured by AOSLO
Description
To evaluate the biological activity of subthreshold photothermal therapy in patients with MacTel Type 2.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Medical College of Wisconsin & Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

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MacTel Laser Study

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