Aflibercept Plus Micropulse Laser Versus Aflibercept Monotherapy for Diabetic Macular Edema

NCT04014556 | Completed

• 1 other identifier: 31181
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• The number of Aflibercept injections in both groups

  The number of Aflibercept injections in both groups

  12 months

Secondary Outcomes (2)

• The changes in visual acuity in both groups.

  12 months

• The changes in central macular thickness in both groups.

  12 months

Study Arms (2)

Aflibercept plus micropulse laser (group A)

ACTIVE COMPARATOR

Overall 40 patients were included in the study; they were randomized into either group A (Aflibercept + Micropulse; 20 patients) or group B (Aflibercept monotherapy; 20 patients).

Device: micropulse laser; Drug: Aflibercept

Aflibercept monotherapy (group B)

ACTIVE COMPARATOR

Overall 40 patients were included in the study; they were randomized into either group A (Aflibercept + Micropulse; 20 patients) or group B (Aflibercept monotherapy; 20 patients).

Drug: Aflibercept

Interventions

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 plus micropulse laser (group A)

Aflibercept DRUG

Aflibercept

Aflibercept monotherapy (group B); Aflibercept plus micropulse laser (group A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alexandria: lead

MeSH Terms

Interventions

aflibercept

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: July 10, 2019
• Study Start: April 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share