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

Phase 4

Completed

• Conditions: Retinal Diseases
• Interventions: Drug: Aflibercept and ranibizumab; Drug: Ranibizumab; Drug: Ranibizumab and Aflibercept; Drug: Aflibercept

• Registration Number: NCT02646670
• Lead Sponsor: Instituto de Olhos de Goiania

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Study First Submitted: 2015-12-02
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-03
• Last Update Submitted: 2016-01-03
• Study First Posted: 2016-01-06
• Last Update Posted: 2016-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• patients with Diabetic macular edema

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aflibercept and Ranibizumab	Aflibercept and ranibizumab	- 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
Ranibizumab	Ranibizumab	- 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
Ranibizumab and Aflibercept	Ranibizumab and Aflibercept	- 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
Aflibercept	Aflibercept	- 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

Primary Outcome Measures

Name	Time	Method
Efficacy of Ranibizumab Therapy with Aflibercept in Patients with Diabetic Macular Edema	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.