A Phase 4 interventional study of Ranibizumab and Aflibercept in Retinal Diseases, sponsored by Instituto de Olhos de Goiania. Completed. Per ClinicalTrials.gov, last updated 2016-01-06.
Sponsored by Instituto de Olhos de Goiania · Phase 4, Interventional, and Treatment
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.
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:
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 619 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Instituto de Olhos de Goiania is the lead sponsor of 27 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
- 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
Drug: Ranibizumab
- 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
Drug: 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
Drug: Ranibizumab and Aflibercept
- 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
Drug: Aflibercept and 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
- 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
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.
Time frame: 3 months
No study locations are listed for this record.
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Instituto de Olhos de Goiania