Efficacy of Ranibizumab Therapy With Aflibercept in Patients With Diabetic Macular Edema

The purpose of this study in to compare the efficacy of treatment of diabetic macular edema (DME) using Ranibizumab (Lucenti®), Aflibercept (Eylea®) and Aflibercept (Eylea®) plus Ranibizumab (Lucentis®).

It is a randomized clinical trial that will evaluate the efficacy of the combination of two substances currently used in the treatment of DME. Will be allocated in different four groups randomly pacients who receive treatment with intravitreal injections of ranibizumab, aflibercept or a combination of aflibercept and ranibizumab.

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Key information

Conditions

Retinal Diseases Eye Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

Interventions will be carried out with intravitreal injections in patients with formal indications of diabetic macular edema treatment previously assessed with complete eye examination in Goiania Eye Institute(Instituto de Olhos de Goiânia)

Patients will be divided into four groups:

In the first group will be held three applications of intravitreal ranibizumab 0.1 ml, with one application every month and follow up with Optical Coherence Tomography on days 1, 3, 5, 10 and 30 following the application.
In the second group will be held three applications of Intravitreal Aflibercept 0.1 ml, with one application each month followed by monitoring with Optical Coherence Tomography on days 1, 3, 5, 10 and 30 subsequent
The third group will be held two applications of Ranibizumab 0.1 ml interspersed with one application of Aflibercept 0.1 ml in the second month and subsequent evaluation with Optical Coherence Tomography on days 1, 3, 5, 10 and 30.
In the fourth group will be held two applications of 0.1 ml Aflibercept interspersed with one application of Ranibizumab 0.1 ml in the second month and subsequent evaluation with Optical Coherence Tomography on days 1, 3, 5, 10 and 30.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

patients with Diabetic macular edema

Exclusion criteria

patients without diabetic macular edema, or with diabetic macular edema with other disease that can make confuse about the diagnose

Treatment and study plan

ranibizumab

Drug

In the first group will be held three applications of intravitreal ranibizumab 0.1 ml, with one application every month and follow up with Optical Coherence Tomography

aflibercept

Drug

In the second group will be held three applications of Intravitreal Aflibercept 0.1 ml, with one application each month followed by monitoring with Optical Coherence Tomography

Ranibizumab and Aflibercept

Drug

The third group will be held two applications of Ranibizumab 0.1 ml interspersed with one application of Aflibercept 0.1 ml in the second month and subsequent evaluation with Optical Coherence Tomography

Aflibercept and ranibizumab

Drug

In the fourth group will be held two applications of 0.1 ml Aflibercept interspersed with one application of Ranibizumab 0.1 ml in the second month and subsequent evaluation with Optical Coherence Tomography

Primary outcomes

Efficacy of Ranibizumab Therapy with Aflibercept in Patients with Diabetic Macular Edema

Time frame: 3 months
Were evaluated the therapy with two different drugs used in diabetic retinopathy, and for this were separated twenty patients in four groups:
- First group will be held three applications of intravitreal ranibizumab 0.1 ml, and follow up with OCT.
- Second group will be held three applications of Intravitreal Aflibercept 0.1 ml, and followed by monitoring with OCT.
- Third group will be held two applications of 0.1 ml Aflibercept interspersed with one application of Ranibizumab 0.1 ml in the second month and subsequent evaluation with OCT.
- Fourth group will be held two applications of Ranibizumab 0.1 ml interspersed with one application of Aflibercept 0.1 ml in the second month and subsequent evaluation with OCT.
In all this groups will be observe the time of reduction of macular edema in the days 1, 3, 5, 10 and 30.

Sponsors and collaborators

Lead sponsor

Instituto de Olhos de Goiania

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Jan 6, 2016
Registry last updated: Jan 6, 2016

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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Completed