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Clinical Trial KESTREL: Efficacy and safety of brolucizumab in comparison with aflibercept in diabetic macular edema 03/10/2018

kestrel_horizontal Recruiting

 

Description

This is a phase III, multi-centre, randomised, double-masked, three-group clinical trial that evaluates the efficacy and safety of Brolucizumab administered through intravitreal injections in adult patients with visual disturbance due to diabetic macular edema (DME) in comparison with the administration of aflibercept (EYLEA®).

Main inclusion criteria

Patients ≥18 years old with type 1 or 2 diabetes mellitus and visual disturbance due to diabetic macular edema in the study eye without previous treatment with any anti-VEGF drug.

Visual acuity should be between 20/32 and 20/320.

Aim

The main aim is to demonstrate that brolucizumab is not inferior to aflibercept with respect to visual outcome after the first year of treatment.

About the drug

The findings in previous trials support the start of a phase III programme to evaluate the efficacy and safety of brolucizumab in the treatment of patients with visual disturbance due to DME with the intention of assessing the possibility of reducing treatment burden for patients.

Duration

This trial has a duration of two years.

If you are interested in taking part in a clinical trial, please send us your personal details here and we will assess whether you are eligible.

ClaraRamon1

 

FREQUENTLY ASKED QUESTIONS

Who can take part in this clinical trial?

Patients ≥18 years old with type 1 or 2 diabetes mellitus and visual disturbance due to diabetic macular edema in the study eye without previous treatment with any anti-VEGF drug.

Visual acuity should be between 20/32 and 20/320.

What are the benefits/risks of taking part in a trial

Participation in a clinical trial offers patients a series of advantages: the new treatment gives them the chance to receive state-of-the-art medical care from experts. This is, for the time being, also the only means of access to new drugs which are not available to

Clinical trials are performed in accordance with strict ethical and scientific principles. We at the Institut apply national and international standards and policies in protection of the rights, safety and welfare of participants.

The risks of participation in a clinical trial may derive from the route of administration of the drug on the one hand and the medication on the other. The risks of the former are well-known and generally low; those deriving from the medication are only partially known but are habitually low and restricted to the eye. In any case, the patient will be informed by the investigator of the possible adverse effects and discomfort resulting from his/her participation in the study. These may vary from one patient to another.

Do patients need to pay?

The patients chosen for clinical trials are not charged for treatment and therefore it is completely free of charge.

How long will the trial last?

The duration will be 24 months.

How many times will I have to attend to the Institut de la Màcula?

Once selected to be part of this clinical trial, the patient will have to compulsorily attend the visits scheduled by the study protocol.

 

 

Intravitreal injectionsDiabetic retinopathyDiabetic macular oedemaOCT AngiographyRetina scanFluorescein angiographyOptical coherence tomographyAutofluorescenceVisual field campimetry
Last modified: 26 July, 2019 - 12:38