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Diabetic macular edema (DME) is a sign of diabetic retinopathy that affects central vision. It is also a leading cause of visual decline in younger patients, especially in developing countries like our Arab community. Intra-vitrreal injection of anti-vascular endothelial growth factor (AVEGF) in management of DME had significant improvement in the final logMAR Un-corrected Distant Visual Acuity ( UCDVA) and logMAR Best Corrected Distant Visual Acuity (BCDVA), as well as reduction in the central retinal thickness from baseline measurement.
The investigators randomly assigned four hundreds eyes of diabetic patients with central diabetic macular edema for intra-vitreal injection of AVEGF group I (200 patients eyes) received aflibercept 2.0 mg and group II (200 patients eyes) received ranibizumab 0.3 mg. Injection was at 4 weeks interval according to the used protocol. The primary outcome was measuring the mean change in visual acuity as functional outcome and the secondary outcomes were the mean change in central macular thickness, as anatomical outcome rather than safety and efficacy of those two anti-VEGF drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AFLIBERCEPT | Active Comparator | Intra-vitreal injection of AFLIBERCEPT |
|
| RANIBIZUMAB | Active Comparator | Intra-vitreal injection of RANIBIZUMAB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept | Drug | Intra-vitreal injection of AVEGF AFLIBERCEPT in group I |
|
| Measure | Description | Time Frame |
|---|---|---|
| measuring the main change in visual acuity | measuring the main change in visual acuity in logarithm of the minimum angle of resolution (log MAR) using projector chart as functional outcome | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| the main change in central macular thickness | the main change in central macular thickness in micrometer by using optical coherence tomography (OCT) as anatomical outcome | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaaban AM Elwan, MD | Minia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minia University | Minya | Egypt |
All patients provided informed written consent for their medical information to be included in analysis and for publication.
2 year
Full PDF
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| ID | Term |
|---|---|
| C533178 | aflibercept |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Ranibizumab | Drug | Intra-vitreal injection of AVEGF Ranibizumab in group 2 |
|
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |