Efficacy of Ranibizumab Therapy With Aflibercept in Patients With Diabetic Macular Edema
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2015
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 2, 2015
CompletedFirst Posted
Study publicly available on registry
January 6, 2016
CompletedJanuary 6, 2016
January 1, 2016
3 months
December 2, 2015
January 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
Ranibizumab
ACTIVE COMPARATOR\- 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
Aflibercept
ACTIVE COMPARATOR\- 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
Ranibizumab and Aflibercept
ACTIVE COMPARATOR\- 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 and Ranibizumab
ACTIVE COMPARATOR\- 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
Interventions
\- 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
\- 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
\- 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
\- 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
You may qualify if:
- patients with Diabetic macular edema
You may not qualify if:
- patients without diabetic macular edema, or with diabetic macular edema with other disease that can make confuse about the diagnose
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2015
First Posted
January 6, 2016
Study Start
July 1, 2015
Primary Completion
October 1, 2015
Study Completion
November 1, 2015
Last Updated
January 6, 2016
Record last verified: 2016-01