Retinal Diseases
Conditions
Keywords
diabetic macular edema, aflibercept, ranibizumab
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.
Interventions
DRUGRanibizumab
\- 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
DRUGAflibercept
\- 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
DRUGRanibizumab 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
DRUGAflibercept 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
Sponsors
Instituto de Olhos de Goiania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed