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

Keyvan Koushan

Status and phase

Completed

Phase 3

Phase 2

Conditions

Diabetic Macular Edema

Treatments

Device: Sham Laser

Combination Product: Micropulse Laser

Study type

Interventional

Funder types

Other

Identifiers

NCT03143192

19228

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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