Efficacy of Ranibizumab Therapy With Aflibercept in Patients With Diabetic Macular Edema
NCT ID: NCT02646670
Last Updated: 2016-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2015-07-31
2015-11-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
\- 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
\- 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
Aflibercept
\- 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
\- 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
Ranibizumab and Aflibercept
\- 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
\- 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
Aflibercept and ranibizumab
\- 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
Interventions
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Ranibizumab
\- 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
\- 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
\- 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
\- 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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Instituto de Olhos de Goiania
OTHER
Responsible Party
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Other Identifiers
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ARVO R2 2016
Identifier Type: -
Identifier Source: org_study_id
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