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Completed

NCT Number: NCT04014556

Aflibercept Plus Micropulse Laser Versus Aflibercept Monotherapy for Diabetic Macular Edema

Purpose: To evaluate the role of adjuvent micropulse laser with Aflibercept injections in the management of treatment naïve centre involving DME, looking at decreased treatment burden and increased efficacy as outcomes.

Methods: This was a prospective, single centre, randomized trial that included 40 eyes (40 patients) with previously untreated centre involved DME. Patients were randomly assigned to receive either Aflibercept plus micropulse laser (group A) or Aflibercept monotherapy (group B).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Patients were randomly distributed in a 1:1 ratio between the two studied groups. Group A received 3 monthly injections of Aflibercept 2 mg/0.05 mL (Eylea; Bayer, Berlin, Germany) as a loading dose, followed one month later by one 577 nm yellow micropulse laser session with monthly PRN Aflibercept injections. Group B received 3 monthly injections of Aflibercept 2 mg/0.05 mL as a loading dose, followed by monthly PRN Aflibercept injections. Patients in both groups were assessed one month after the end of loading phase; At this point, group A received the micropulse laser session and started PRN Aflibercept injections, while group B started PRN Aflibercept injections without receiving the micropulse laser session. After that, both groups were followed for 12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients were older than 18 with the clinical diagnosis of previously untreated centre involved DME documented by fluorescein angiography and central macular thickness (CMT) ≥ 300 µm on the spectral-domain OCT Best corrected visual acuity was better than 3/60 with Hb A1C less than 10%.

Exclusion criteria

  • any previous treatment for DME, proliferative diabetic retinopathy, macular ischemia on fluorescein angiography, epiretinal membrane or tractional maculopathy on OCT, media opacity and any previous intraocular surgery with the exception of uneventful cataract surgery more than 6 months before the beginning of the study.

Treatment and study plan

micropulse laser

Device

Micropulse session details:

Mainster focal grid contact lens (×1.05 laser magnification) was used to perform laser. The 577-nm yellow laser (OcuLight SLx, Iridex Corp., Mountain View, California, USA) was used. Fixed treatment parameters were used in all cases: 200-μm spot size, 200-ms exposure duration, 400-mW power, and a 5% duty cycle. Confluent applications with no spacing were administered using 5x5 grid pattern over the entire edematous area including the fovea.

aflibercept

Drug

Aflibercept

Primary outcomes

  1. The number of Aflibercept injections in both groups

    Time frame: 12 months

    The number of Aflibercept injections in both groups

Secondary outcomes

  1. The changes in visual acuity in both groups.

    Time frame: 12 months

    best corrected visual acuity in both groups at one year.

  2. The changes in central macular thickness in both groups.

    Time frame: 12 months

    central macular thickness in both groups at one year

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Official study title

Aflibercept Plus Micropulse Laser Versus Aflibercept Monotherapy for Diabetic Macular Edema. One Year Results of a Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 10, 2019
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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