- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02646670
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
- 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
|
Active Comparator: 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
|
- 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
|
Active Comparator: 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
|
- 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
|
Active Comparator: 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
|
- 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARVO R2 2016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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