Treatment of Diabetic Macular Edema With Aflibercept and Micropulse Laser

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-08

Study Completion Date

2019-05-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Aflibercept with Micropulse Laser

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

Group Type EXPERIMENTAL

Micropulse Laser

Intervention Type COMBINATION_PRODUCT

Aflibercept injection with Micropulse laser.

Aflibercept with Sham Laser

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

Group Type SHAM_COMPARATOR

Sham Laser

Intervention Type DEVICE

Aflibercept injection with Sham Laser

Interventions

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Micropulse Laser

Aflibercept injection with Micropulse laser.

Intervention Type COMBINATION_PRODUCT

Sham Laser

Aflibercept injection with Sham Laser

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes