Back to results

Sub-threshold Photocoagulation of Diabetic Macular Oedema (MEM)

Primary Purpose

Diabetic Macular Oedema

Status

Withdrawn

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

PASCAL Laser, Green Laser 0.75

PASCAL Laser, Green Laser 1

PASCAL Laser, 70% Yellow Laser 0.75

PASCAL Laser, 70% Yellow Laser 1

PASCAL Laser, 40% Yellow Laser 0.75

PASCAL Laser, 40% Yellow Laser 1

About this trial

This is an interventional treatment trial for Diabetic Macular Oedema focused on measuring diffuse diabetic macular oedema, Pascal, Laser, DMO

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient-eligibility

Inclusion criteria:

Older than 18 years of age
Male or female patients with diabetes mellitus type I or type 2 who meet the WHO or ADA criteria for diabetes
Able to give informed consent

Study Eye eligibility

Inclusion criteria:

ETDRS visual acuity equivalent to 35 letters or better (Snellen equivalent 20/200 or better)
The patient must have non-proliferative diabetic retinopathy (NPDR) with diffuse macular oedema
Mean average central retinal thickness at least 300 microns as measured by Deep Range Imaging Optical Coherence Tomography (DRI -OCT) scans
Adequate pupil dilatation and clear media to perform wide-field colour, red-free imaging and fundus fluorescein angiography (WF-FFA), wide-field fundus autofluorescence imaging (WF-AF) and DRI-OCT
Ability to perform accurate Humphmrey visual field test

Exclusion Criteria:

Patient-eligibility

Exclusion criteria:

History of chronic renal failure or renal transplant for diabetic nephropathy
Recent (last 6 months) or on-going poor glycaemic control. H1Ac greater than 10.0mg/dL
Creatinine greater than 1.2 mg/dL
HDL equal to or greater than 40 mg/dL
Uncontrolled hypertension. Blood pressure greater or equal to 180/110 mmHg
Patient is unavailable for follow-up visits
Pregnant women or breast-feeding females

Study Eye eligibility

Exclusion criteria:

Lens opacity that could influence vision and results
Proliferative Diabetic Retinopathy.
Any surgical or non-retinal laser treatment to the study eye within 2 months
Narrow drainage angles with raised intraocular pressure and angle closure glaucoma.
Planned YAG peripheral iridotomy
Previous retinal laser photocoagulation, intraocular drug therapy, or macular laser treatment to treatment eye in last year
Vitreomacular traction determined clinically and / or OCT, which in the opinion of the investigator, contributes to macular edema (associated or cause a detachment of the fovea) and prevents the improvement with treatment.
Atrophy / scar / fibrosis involving the center of the macula, including evidence of atrophy treated with laser within 200 microns of the FAZ.
Any previous ocular condition that may be associated with a risk of macular edema
Important known allergies to sodium fluorescein dye used in angiography.

12. Active lid or adnexal infection 13. Planned intra-ocular surgery within one year

Sites / Locations

Central Manchester Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

PASCAL Laser, Green Laser 0.75

PASCAL Laser, Green Laser 1 burn

PASCAL Laser, 70% Yellow Laser 0.75

PASCAL Laser, 70% Yellow Laser 1

PASCAL Laser, 40% Yellow Laser 0.75

PASCAL Laser, 40% Yellow Laser 1

Arm Description

Barely Visible Pascal laser grid using 532nm "green" wavelength, 0.75 burn-widths-apart. Intervention: macular laser grid Number of burns: Full grid 112 burns Spot size: 100micron Duration: 10 ms Exposure: barely visible burn Average power: 100 to 1000 mW Spot spacing: 0.75 burn-widths-apart Distribution: Grid

Barely Visible Pascal laser grid using 532nm "green" wavelength, 1 burn-widths-apart Intervention: macular laser grid Number of burns: Full grid 112 burns Spot size: 100micron Duration: 10 ms Exposure: barely visible burn Average power: 100 to 1000 mW Spot spacing: 1 burn-widths-apart Distribution: Grid

Pascal EM at 70% 577nm "yellow" laser grid, 0.75 burn-widths-apart Intervention: macular laser grid Number of burns: Full grid 112 burns Spot size: 100micron Duration: 10 ms Exposure: A barely visible burn will be aimed at for the "Landmark" burn and EndPoint Management will be set at 70% to achieve non-visible burns Average power: 100 to 1000 mW Spot spacing: 0.75 burn-widths-apart Distribution: Grid

Pascal EM at 70% 577nm "yellow", 1 burn-widths-apart Intervention: macular laser grid Number of burns: Full grid 112 burns Spot size: 100micron Duration: 10 ms Exposure: A barely visible burn will be aimed at for the "Landmark" burn and EndPoint Management will be set at 70% to achieve non-visible burns Average power: 100 to 1000 mW Spot spacing: 1 burn-widths-apart Distribution: Grid

Pascal EM at 40% 577nm "yellow", 0.75 burn-widths-apart Intervention: macular laser grid Number of burns: Full grid 112 burns Spot size: 100micron Duration: 10 ms Exposure: A barely visible burn will be aimed at for the "Landmark" burn and EndPoint Management will be set at 40% to achieve non-visible burns Average power: 100 to 1000 mW Spot spacing: 0.75 burn-widths-apart Distribution: Grid

Pascal EM at 40% 577nm "yellow" laser grid, 1 burn-widths-apart Intervention: macular laser grid Number of burns: Full grid 112 burns Spot size: 100micron Duration: 10 ms Exposure: A barely visible burn will be aimed at for the "Landmark" burn and EndPoint Management will be set at 40% to achieve non-visible burns Average power: 100 to 1000 mW Spot spacing: 1 burn-widths-apart Distribution: Grid

Outcomes

Primary Outcome Measures

reduction of diabetic macular edema (central retinal thickness) within the 6 arms of the study

To compare Green Pascal® laser and Yellow Pascal® laser using EM among 6 groups of participants using Pascal® laser with an application of full grid 112 burns in a single session

Secondary Outcome Measures

Improvement in visual acuity (> 10 letters or two lines in the ETDRS chart)

increase in retinal sensitivity within the 6 arms of the study

increase in retinal sensitivity will be assessed with fundus-related perimetry (microperimetry)

Full Information

NCT ID

NCT02309476

First Posted

September 29, 2014

Last Updated

March 16, 2020

Sponsor

Manchester University NHS Foundation Trust

Collaborators

Topcon Corporation, Optos, PLC

1. Study Identification

Unique Protocol Identification Number

NCT02309476

Brief Title

Sub-threshold Photocoagulation of Diabetic Macular Oedema

Acronym

MEM

Official Title

Manchester Pascal Endpoint Management Laser Treatment of Diffuse Diabetic Macular Oedema (DMO): A Safety and Efficacy Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Withdrawn

Why Stopped

The PI decided to close the study early as patients with diffused macular oedema without any previous treatment are uncommon.

Study Start Date

October 2012 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Manchester University NHS Foundation Trust

Collaborators

Topcon Corporation, Optos, PLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Topcon's Endpoint Management (EM) is a new software from the Pascal® laser which allows us to decrease the intensity of the burns (invisible burns) showing some landmarks with normal intensity so the investigators can see the area which has been treated. The Pascal® system with EM utilizes 577nm laser wavelength compared to the 532nm laser wavelength which was utilized in previous Pascal® laser studies. This study aims to demonstrate that 577nm Pascal® with EM has the same efficacy and effectiveness as 532nm Pascal® in the treatment of diabetic macular oedema.

Detailed Description

Diabetic macular oedema (DMO) remains the most common cause of visual loss in diabetic patients and affects around 29% of diabetic patients with 20 or more years of disease. The Early Treatment Diabetic Retinopathy Study (ETDRS) demonstrated a significant benefit of laser photocoagulation for the treatment of clinically significant macular oedema, reducing the incidence of vision loss by approximately 50% at 3 years' follow-up. The original ETDRS photocoagulation technique was adopted throughout the world and gradually modified through the years. Despite the great improvements, loss of central vision, paracentral scotoma and decreased color vision are some adverse events that can still occur, mostly caused by the progressive enlargement of the laser scars consequent to the visible burn of conventional laser photocoagulation. New strategies have been developed for laser treatments that minimize the chorioretinal damage while maintaining at least similar treatment efficacy. And numerous clinical studies have been conducted with subvisible laser treatments. However, the lack of a visible endpoint makes it difficult for the treating physician to know which retinal areas have been treated in order to avoid retreatment and also to be confident that the desired target tissue had been treated. Topcon's Endpoint Management (EM) is a new software from the Pascal® laser which allows us to decrease the intensity of the burns (invisible burns) showing some landmarks with normal intensity so the investigators can see the area which has been treated. The Pascal® system with EM utilizes 577nm laser wavelength compared to the 532nm laser wavelength which was utilized in previous Pascal® laser studies. This study aims to demonstrate that 577nm Pascal® with EM has the same efficacy and effectiveness as 532nm Pascal®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Oedema

Keywords

diffuse diabetic macular oedema, Pascal, Laser, DMO

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PASCAL Laser, Green Laser 0.75

Arm Type

Experimental

Arm Description

Arm Title

PASCAL Laser, Green Laser 1 burn

Arm Type

Experimental

Arm Description

Arm Title

PASCAL Laser, 70% Yellow Laser 0.75

Arm Type

Experimental

Arm Description

Arm Title

PASCAL Laser, 70% Yellow Laser 1

Arm Type

Experimental

Arm Description

Arm Title

PASCAL Laser, 40% Yellow Laser 0.75

Arm Type

Experimental

Arm Description

Arm Title

PASCAL Laser, 40% Yellow Laser 1

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

PASCAL Laser, Green Laser 0.75

Intervention Description

Intervention Type

Device

Intervention Name(s)

PASCAL Laser, Green Laser 1

Intervention Description

Barely Visible Pascal laser grid using 532nm "green" wavelength, 1 burn-widths-apart. Intervention: macular laser grid Number of burns: Full grid 112 burns Spot size: 100micron Duration: 10 ms Exposure: barely visible burn Average power: 100 to 1000 mW Spot spacing: 0.75 burn-widths-apart Distribution: Grid

Intervention Type

Device

Intervention Name(s)

PASCAL Laser, 70% Yellow Laser 0.75

Intervention Description

Intervention Type

Device

Intervention Name(s)

PASCAL Laser, 70% Yellow Laser 1

Intervention Description

Intervention Type

Device

Intervention Name(s)

PASCAL Laser, 40% Yellow Laser 0.75

Intervention Description

Pascal EM at 40% 577nm "yellow" laser grid, 0.75 burn-widths-apart Intervention: macular laser grid Number of burns: Full grid 112 burns Spot size: 100micron Duration: 10 ms Exposure: A barely visible burn will be aimed at for the "Landmark" burn and EndPoint Management will be set at 740% to achieve non-visible burns Average power: 100 to 1000 mW Spot spacing: 0.75 burn-widths-apart Distribution: Grid

Intervention Type

Device

Intervention Name(s)

PASCAL Laser, 40% Yellow Laser 1

Intervention Description

Primary Outcome Measure Information:

Title

reduction of diabetic macular edema (central retinal thickness) within the 6 arms of the study

Description

To compare Green Pascal® laser and Yellow Pascal® laser using EM among 6 groups of participants using Pascal® laser with an application of full grid 112 burns in a single session

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Improvement in visual acuity (> 10 letters or two lines in the ETDRS chart)

Time Frame

12 months

Title

increase in retinal sensitivity within the 6 arms of the study

Description

increase in retinal sensitivity will be assessed with fundus-related perimetry (microperimetry)

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient-eligibility Inclusion criteria: Older than 18 years of age Male or female patients with diabetes mellitus type I or type 2 who meet the WHO or ADA criteria for diabetes Able to give informed consent Study Eye eligibility Inclusion criteria: ETDRS visual acuity equivalent to 35 letters or better (Snellen equivalent 20/200 or better) The patient must have non-proliferative diabetic retinopathy (NPDR) with diffuse macular oedema Mean average central retinal thickness at least 300 microns as measured by Deep Range Imaging Optical Coherence Tomography (DRI -OCT) scans Adequate pupil dilatation and clear media to perform wide-field colour, red-free imaging and fundus fluorescein angiography (WF-FFA), wide-field fundus autofluorescence imaging (WF-AF) and DRI-OCT Ability to perform accurate Humphmrey visual field test Exclusion Criteria: Patient-eligibility Exclusion criteria: History of chronic renal failure or renal transplant for diabetic nephropathy Recent (last 6 months) or on-going poor glycaemic control. H1Ac greater than 10.0mg/dL Creatinine greater than 1.2 mg/dL HDL equal to or greater than 40 mg/dL Uncontrolled hypertension. Blood pressure greater or equal to 180/110 mmHg Patient is unavailable for follow-up visits Pregnant women or breast-feeding females Study Eye eligibility Exclusion criteria: Lens opacity that could influence vision and results Proliferative Diabetic Retinopathy. Any surgical or non-retinal laser treatment to the study eye within 2 months Narrow drainage angles with raised intraocular pressure and angle closure glaucoma. Planned YAG peripheral iridotomy Previous retinal laser photocoagulation, intraocular drug therapy, or macular laser treatment to treatment eye in last year Vitreomacular traction determined clinically and / or OCT, which in the opinion of the investigator, contributes to macular edema (associated or cause a detachment of the fovea) and prevents the improvement with treatment. Atrophy / scar / fibrosis involving the center of the macula, including evidence of atrophy treated with laser within 200 microns of the FAZ. Any previous ocular condition that may be associated with a risk of macular edema Important known allergies to sodium fluorescein dye used in angiography. 12. Active lid or adnexal infection 13. Planned intra-ocular surgery within one year

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paulo Stanga

Organizational Affiliation

Manchester Royal Eye Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Central Manchester Foundation Trust

City

Manchester

State/Province

England

ZIP/Postal Code

M13 9WL

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Sub-threshold Photocoagulation of Diabetic Macular Oedema

We'll reach out to this number within 24 hrs