NCT03321916

Completed

MacTel Laser Study

The Lowy Medical Research Institute Limited Source

Compare

Other study identifiers

Sponsor study identifier

MacTelLaser1

Study Type

interventional

Actual enrollment (reported)

9

Locations

1 country

Sites

1

Timeline

Study Start

February 8, 2018

Actual (reported)

Primary Completion

December 31, 2022

Actual (reported)

Study Completion

December 31, 2022

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 9 participants
Study completion date: December 31, 2022
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
October 18, 2017
Actual (reported)
First Posted
October 26, 2017
Actual (reported)
Study Start
February 8, 2018
Actual (reported)
Primary Completion
December 31, 2022
Actual (reported)
Study Completion
December 31, 2022
Actual (reported)

Last Updated: March 8, 2023
Status Verified: March 2023
Last Update Submitted: March 7, 2023

Conditions

Macular Telangiectasia

Keywords

MacTel

Outcome Measures

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
3 months post treatment

Secondary Outcomes (3)

Change from baseline cone density as measured by confocal adaptive optics (AOSLO)
1 year
Change in size of ellipsoid zone break area as measured by spectral domain optical coherence tomography (SD-OCT)
1 year
Development or extension post therapy of areas of deficiency in cones as measured by AOSLO
1 year

Study Arms (2)

Subthreshold Photothermal Therapy

EXPERIMENTAL

Device: 577-nm PASCAL laser

Sham

SHAM COMPARATOR

Device: 577-nm PASCAL laser

Interventions

577-nm PASCAL laserDevice

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

ShamSubthreshold Photothermal Therapy

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age21 Years - 79 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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;

Sponsors & Collaborators

The Lowy Medical Research Institute Limited
Otherlead

Study Sites (1)

Medical College of Wisconsin & Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Enrollment

9 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 18, 2017

First Posted

October 26, 2017

Study Start

February 8, 2018

Actual (reported)

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.

You may not qualify if:

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;
+4 more criteria

Contact the study team to confirm eligibility.

Primary Completion

December 31, 2022

Actual (reported)

Study Completion

December 31, 2022

Actual (reported)

Last Updated

March 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing: Will share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03321916
Data provider: ClinicalTrials.gov
Source updated: 2023-03-08
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:16 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Subthreshold Photothermal Therapy

Sham

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations