Clinical trial NCT03143192: Treatment of Diabetic Macular Edema With Aflibercept and Micropulse Laser
Official title: Treatment of Diabetic Macular Edema With Aflibercept and Micropulse Laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetic Macular Edema
Keywords: DME, Micropulse Laser, Anti-VEGF
Lead sponsor: Toronto Retina Institute
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of injections for each group
timeFrame: 48 weeks
Secondary outcomes:
measure: Changes in visual acuity
timeFrame: 24 weeks
measure: Changes in visual acuity
timeFrame: 48 weeks
measure: Changes in OCT Central Macular Thickness and Volume
timeFrame: 24 weeks
measure: Changes in OCT Central Macular Thickness and Volume
timeFrame: 48 weeks
measure: Number of injections half way
timeFrame: 24 weeks
measure: Proportion of eyes with 2 or 3 lines of visual gain or loss
timeFrame: 24 weeks
measure: Proportion of eyes with 2 or 3 lines of visual gain or loss
timeFrame: 48 weeks
measure: Proportion of eyes that achieve 20/20 vision
timeFrame: 24 weeks
measure: Proportion of eyes that achieve 20/20 vision
timeFrame: 48 weeks
measure: Proportion of eyes that have PRP, vitreous hemorrhage, and vitrectomy.
timeFrame: 48 weeks
measure: Proportion of eyes that had vision or OCT improvement
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Mississauga Retina Institute
state: Ontario
city: Toronto
country: Canada
facility: Toronto Retina Institute
state: Ontario
Study officials:
affiliation: Toronto Retina Institute
name: Keyvan Koushan, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
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.