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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Retinal Diseases

Intervention / Treatment
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* Drug: Ranibizumab
* Drug: Aflibercept
* Drug: Ranibizumab and Aflibercept
* Drug: Aflibercept and ranibizumab


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ranibizumab<br>- In the first group will be held three applications of intravitreal ranibizumab 0.1 ml . This group will be five about patients about any age, with diabetic macular edema randomly chosen | Drug: Ranibizumab<br>* - 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<br>|
| Active Comparator: Aflibercept<br>- In the second group will be held three applications of Intravitreal Aflibercept 0.1 ml. This group will be about five patients about any age, with diabetic macular edema randomly chosen | Drug: Aflibercept<br>* - 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<br>|
| Active Comparator: Ranibizumab and Aflibercept<br>- In this group will be held two applications of 0.1 ml Aflibercept(the first and the third doses) interspersed with one application of Ranibizumab 0.1 ml(the second dose). This group will be about five patients about any age, with diabetic macular edema randomly chosen | Drug: Ranibizumab and Aflibercept<br>* - 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<br>|
| Active Comparator: Aflibercept and Ranibizumab<br>- This group will be held two applications of Ranibizumab 0.1 ml(the first and the third doses) interspersed with one application of Aflibercept 0.1 ml(the second dose). This group will be five about patients about any age, with diabetic macular edema randomly chosen | Drug: Aflibercept and ranibizumab<br>* - 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Ranibizumab Therapy with Aflibercept in Patients with Diabetic Macular Edema | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic macular edema, aflibercept, ranibizumab