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Treatment of Diabetic Macular Edema With Aflibercept and Micropulse Laser (DAM)

Primary Purpose

Diabetic Macular Edema

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Micropulse Laser

Sham Laser

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring DME, Micropulse Laser, Anti-VEGF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Type I or Type II Diabetes Mellitus
Presence of centre-involved Diabetic Macular Edema (DME) with the Central Macular Thickness (CMT) of ≥ 310µm on the spectral-domain Optical Coherence Tomography (OCT)
Best corrected Visual Acuity (BCVA) between, and including, 20/30 and 20/400 in the study eye.
Patient's willingness and ability to attend the study visits

Exclusion Criteria:

Any other potential causes of macular edema such as active uveitis, epiretinal membrane, post-operative CME, and vitromacular traction
Any history of major intraocular surgery (such as cataract surgery or vitrectomy) in the study eye within prior six months, or anticipated need for intraocular surgery within the next six months from the enrollment
Any major ocular pathology limiting potential vision such as large macular scars, vitreous hemorrhage, corneal opacities, visually significant cataracts, advanced glaucoma, or other types of optic neuropathy
Any history of Panretinal Photocoagulation (PRP) in the study eye or anticipated need for PRP within the next 6 months from enrollment
Any history of DME treatment (focal laser, anti-VEGF, or intraocular/periocular steroids) in the study eye in the past 4 months prior to the enrollment
Significant renal disease requiring dialysis
Significant heart disease, stroke or transient ischemic attack requiring hospitalization in the past 4 months prior to the study
Presence of active ocular or periocular infection
Presence of active intraocular inflammation
Known hypersensitivity to aflibercept or to any ingredient in the formulation or to any component of the container

Sites / Locations

Mississauga Retina Institute
Toronto Retina Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Aflibercept with Micropulse Laser

Aflibercept with Sham Laser

Arm Description

Aflibercept 2mg (0.05mL) injected intravitreally every 4 weeks or as needed Micropulse Laser at initial visit and reassessed every 12 weeks.

Aflibercept 2mg (0.05mL) injected intravitreally every 4 weeks or as needed Sham Laser at initial visit and reassessed every 12 weeks.

Outcomes

Primary Outcome Measures

Number of injections for each group

Number of intravitreal injections for each group

Secondary Outcome Measures

Changes in visual acuity

Changes in visual acuity from baseline to 24 adjusted for baseline

Changes in visual acuity

Changes in visual acuity from baseline to 48 weeks adjusted for baseline

Changes in OCT Central Macular Thickness and Volume

Measurement changes in central macular thickness at 24 weeks

Changes in OCT Central Macular Thickness and Volume

Measurement changes in central macular thickness at 48 weeks

Number of injections half way

Number of intravitreal injections of each group at 24 weeks

Proportion of eyes with 2 or 3 lines of visual gain or loss

Improvement or deterioration of vision of 2 or 3 lines at 24 weeks

Proportion of eyes with 2 or 3 lines of visual gain or loss

Improvement or deterioration of vision of 2 or 3 lines at 48 weeks

Proportion of eyes that achieve 20/20 vision

Eyes that are able to see 20/20 at 24 weeks regardless of baseline

Proportion of eyes that achieve 20/20 vision

Eyes that are able to see 20/20 at 48 weeks regardless of baseline

Proportion of eyes that have PRP, vitreous hemorrhage, and vitrectomy.

Proportion of eyes in each study group that require panretinal photocoagulation, have a vitreous hemorrhage, or require a vitrectomy during the course of the study.

Proportion of eyes that had vision or OCT improvement

In patients with HbA1c ≤ 8% or separately measured in patients with HbA1C > 8%

Full Information

NCT ID

NCT03143192

First Posted

May 1, 2017

Last Updated

September 9, 2019

Sponsor

Keyvan Koushan

1. Study Identification

Unique Protocol Identification Number

NCT03143192

Brief Title

Treatment of Diabetic Macular Edema With Aflibercept and Micropulse Laser

Acronym

DAM

Official Title

Treatment of Diabetic Macular Edema With Aflibercept and Micropulse Laser

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

March 8, 2017 (Actual)

Primary Completion Date

May 9, 2019 (Actual)

Study Completion Date

May 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Keyvan Koushan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The goal of this pilot study is to investigate the safety and efficacy of micropulse (MP) macular laser in combination with intravitreal aflibercept for the treatment of centre-involved diabetic macular edema.

Detailed Description

Diabetic macular edema (DME) is one of the major causes of visual decline among diabetic patients. Early Treatment of Diabetic Retinopathy Study has established focal/grid macular laser as the standard of treatment for clinically significant macular edema. More recently, intravitreal injections of anti-VEGF agents, either as monotherapy or in combination with focal/grid laser, have proven to be superior for the treatment of DME compared to laser alone. Micropulse (MP) macular laser involves applying the laser in a fraction of the time within very small pockets of energy. Unline traditional focal/grid macular laser, the micropulse method of delivery does not leave any visible burns on the retina. A recent release by the Diabetic Retinopathy Clinical Research Network has shown that deferring focal/grid laser and treating diabetic macular edema with only anti-VEGF may lead to better visual outcomes. Since MP laser does not have the undesired side effect of leaving laser scars on the macula, the study is to show that prompt MP laser in addition to anti-vegf injections may lead to better visual outcomes and/or decreased treatment burden without the undesired side effect of macular scarring.

6. Conditions and Keywords

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

Diabetic Macular Edema

Keywords

DME, Micropulse Laser, Anti-VEGF

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

This will be a parallel study comparing the results of patients who receive aflibercept and micropulse laser versus those who only receive aflibercept. The second group will receive sham laser to prevent placebo effects.

Masking

ParticipantOutcomes Assessor

Masking Description

Patients and technicians (measuring ocular coherence tomography, fluorescein auto fluorescence and visual acuity) will be masked. The investigator and study coordinator will be unmasked to direct the patient.

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aflibercept with Micropulse Laser

Arm Type

Experimental

Arm Description

Aflibercept 2mg (0.05mL) injected intravitreally every 4 weeks or as needed Micropulse Laser at initial visit and reassessed every 12 weeks.

Arm Title

Aflibercept with Sham Laser

Arm Type

Sham Comparator

Arm Description

Aflibercept 2mg (0.05mL) injected intravitreally every 4 weeks or as needed Sham Laser at initial visit and reassessed every 12 weeks.

Intervention Type

Combination Product

Intervention Name(s)

Micropulse Laser

Intervention Description

Aflibercept injection with Micropulse laser.

Intervention Type

Device

Intervention Name(s)

Sham Laser

Intervention Description

Aflibercept injection with Sham Laser

Primary Outcome Measure Information:

Title

Number of injections for each group

Description

Number of intravitreal injections for each group

Time Frame

48 weeks

Secondary Outcome Measure Information:

Title

Changes in visual acuity

Description

Changes in visual acuity from baseline to 24 adjusted for baseline

Time Frame

24 weeks

Title

Changes in visual acuity

Description

Changes in visual acuity from baseline to 48 weeks adjusted for baseline

Time Frame

48 weeks

Title

Changes in OCT Central Macular Thickness and Volume

Description

Measurement changes in central macular thickness at 24 weeks

Time Frame

24 weeks

Title

Changes in OCT Central Macular Thickness and Volume

Description

Measurement changes in central macular thickness at 48 weeks

Time Frame

48 weeks

Title

Number of injections half way

Description

Number of intravitreal injections of each group at 24 weeks

Time Frame

24 weeks

Title

Proportion of eyes with 2 or 3 lines of visual gain or loss

Description

Improvement or deterioration of vision of 2 or 3 lines at 24 weeks

Time Frame

24 weeks

Title

Proportion of eyes with 2 or 3 lines of visual gain or loss

Description

Improvement or deterioration of vision of 2 or 3 lines at 48 weeks

Time Frame

48 weeks

Title

Proportion of eyes that achieve 20/20 vision

Description

Eyes that are able to see 20/20 at 24 weeks regardless of baseline

Time Frame

24 weeks

Title

Proportion of eyes that achieve 20/20 vision

Description

Eyes that are able to see 20/20 at 48 weeks regardless of baseline

Time Frame

48 weeks

Title

Proportion of eyes that have PRP, vitreous hemorrhage, and vitrectomy.

Description

Proportion of eyes in each study group that require panretinal photocoagulation, have a vitreous hemorrhage, or require a vitrectomy during the course of the study.

Time Frame

48 weeks

Title

Proportion of eyes that had vision or OCT improvement

Description

In patients with HbA1c ≤ 8% or separately measured in patients with HbA1C > 8%

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Type I or Type II Diabetes Mellitus Presence of centre-involved Diabetic Macular Edema (DME) with the Central Macular Thickness (CMT) of ≥ 310µm on the spectral-domain Optical Coherence Tomography (OCT) Best corrected Visual Acuity (BCVA) between, and including, 20/30 and 20/400 in the study eye. Patient's willingness and ability to attend the study visits Exclusion Criteria: Any other potential causes of macular edema such as active uveitis, epiretinal membrane, post-operative CME, and vitromacular traction Any history of major intraocular surgery (such as cataract surgery or vitrectomy) in the study eye within prior six months, or anticipated need for intraocular surgery within the next six months from the enrollment Any major ocular pathology limiting potential vision such as large macular scars, vitreous hemorrhage, corneal opacities, visually significant cataracts, advanced glaucoma, or other types of optic neuropathy Any history of Panretinal Photocoagulation (PRP) in the study eye or anticipated need for PRP within the next 6 months from enrollment Any history of DME treatment (focal laser, anti-VEGF, or intraocular/periocular steroids) in the study eye in the past 4 months prior to the enrollment Significant renal disease requiring dialysis Significant heart disease, stroke or transient ischemic attack requiring hospitalization in the past 4 months prior to the study Presence of active ocular or periocular infection Presence of active intraocular inflammation Known hypersensitivity to aflibercept or to any ingredient in the formulation or to any component of the container

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Keyvan Koushan, MD, FRCSC

Organizational Affiliation

Toronto Retina Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mississauga Retina Institute

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L4X 2Z9

Country

Canada

Facility Name

Toronto Retina Institute

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M3C 0G9

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The results of this study will be analyzed statistically which will be shared with other members of the scientific community but the individual participant data along with their identifiers will not be available to other researchers.

Citations:

PubMed Identifier

35422607

Citation

Koushan K, Eshtiaghi A, Fung P, Berger AR, Chow DR. Treatment of Diabetic Macular Edema with Aflibercept and Micropulse Laser (DAM Study). Clin Ophthalmol. 2022 Apr 8;16:1109-1115. doi: 10.2147/OPTH.S360869. eCollection 2022.

Results Reference

derived

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Treatment of Diabetic Macular Edema With Aflibercept and Micropulse Laser

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