NCT04087746

Comparison of Aflibercept Versus Ranibizumab in Management of Diabetic Macular Edema (DME)

Comparison of Aflibercept Versus Ranibizumab in Management of Diabetic Macular Edema

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Minia University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Aflibercept	Intra-vitreal injection of AVEGF AFLIBERCEPT in group I
DRUG	Ranibizumab	Intra-vitreal injection of AVEGF Ranibizumab in group 2

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-01-01
• Completion: 2019-06-01
• First posted: 2019-09-12
• Last updated: 2019-09-12

Locations

1 site across 1 country: Egypt