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

Sponsor
Minia University
Study ID
NCT04087746
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept — DRUG
    Intra-vitreal injection of AVEGF AFLIBERCEPT in group I
  • Ranibizumab — DRUG
    Intra-vitreal injection of AVEGF Ranibizumab in group 2

Study Details

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.

Key Dates

Start date
Jan 31, 2017
Status verified
Sep 2019
Primary completion
Jan 31, 2019
Completion
Jun 30, 2019

Study Design

Enrollment
400 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: AFLIBERCEPT
    Intra-vitreal injection of AFLIBERCEPT
  • Active Comparator: RANIBIZUMAB
    Intra-vitreal injection of RANIBIZUMAB

Primary Outcome Measure

measuring the main change in visual acuity [ Time Frame: 2 years ]

Related Studies