Overview

Aflibercept Plus Micropulse Laser Versus Aflibercept Monotherapy for Diabetic Macular Edema

Status:
Completed
Trial end date:
2018-12-01
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Alexandria
Treatments:
Aflibercept
Criteria
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.