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Aflibercept anD navigateD vErsus coNvensional Laser in Diabetic macUlar edeMa

NCT02554747 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-03-19

No results posted yet for this study

Summary

Diabetic macular edema (DME) in diabetic retinopathy (DR) is the leading cause of visual impairment among the 300,000 Danish patients with diabetes (DM) and will in time affect 29% of patients. Because of DME, 550 intravitreal injections were given at Odense University Hospital in 2014 with medicine expenses approximating 3.3 million DKK. With an increasing prevalence of diabetes, the number is expected to rise significantly for the years to come.

The investigators hypothesize that combination therapy with intravitreal aflibercept and a new computer navigated photocoagulations system (Navilas®) leads to a decreased need for intravitreal injections.

Further, the investigators wish to identify retinal risk markers for DME treatment outcome to assist individualized treatment planning. The evaluation of the baseline level of macular ischemia as marker of successful treatment outcome is of particular interest as this is still highly debatable and may prove a significant prognostic factor of anatomical and functional outcome to anti-VEGF treatment.

The ADDENDUM study (four-year part-time PhD study) is a 12-month prospective randomized 1:1 study to compare intravitreal aflibercept and Navilas® laser (Group A) with intravitreal aflibercept and conventional Pascal laser (Group B) in the treatment of DME.

Eligibility criteria: DM, age 18-99, clinically significant macular edema, central retinal thickness \> 300 μm, best corrected visual acuity 35-75 Early Treatment Diabetic Retinopathy Study (ETDRS) letters.

The investigators believe that this study holds the potential to set precedent for a new gold standard of DME-treatment with increased treatment effect, reduced risks and a more cost-effective approach.

Conditions

  • Diabetic Macular Oedema

Interventions

DEVICE

Navigated laser

Aflibercept, Navilas®

DEVICE

Conventional laser

Aflibercept, Pascal

Sponsors & Collaborators

  • Moorfields Eye Hospital NHS Foundation Trust

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Søren Leer Blindbæk, MD · Research Unit of Ophthalmology, Clinical Institute, University of Southern Denmark and Department of Ophthalmology, Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-12-31
Completion
2018-11-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02554747 on ClinicalTrials.gov