Comparison of Aflibercept Versus Ranibizumab in Management of Diabetic Macular Edema
Overview
- Phase
- Phase 4
- Intervention
- Aflibercept
- Conditions
- Diabetic Macular Edema
- Sponsor
- Minia University
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- measuring the main change in visual acuity
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Shaaban Elwan
Assistant professor of ophthalmology
Minia University
Eligibility Criteria
Inclusion Criteria
- •Patients with type 1 or 2 diabetes mellitus with central DME clinically as well as documented by optical coherence tomography (OCT) imaging
- •The age of the patients at least 20 years old
- •Patients not receiving AVEGF injection, at least for one year
- •The BCDVA letter score of at least one eye (range, 0 to 115, with higher scores indicating better visual acuity of 90 (Snellen = 20/32) to 40 (Snellen = 20/320) and central DME .
Exclusion Criteria
- •Patients with cataract
- •Glaucoma patient
- •Previous AVEGF injection in less than one year
- •Patients not attending all of the scheduled follow up visits
Arms & Interventions
AFLIBERCEPT
Intra-vitreal injection of AFLIBERCEPT
Intervention: Aflibercept
RANIBIZUMAB
Intra-vitreal injection of RANIBIZUMAB
Intervention: Ranibizumab
Outcomes
Primary Outcomes
measuring the main change in visual acuity
Time Frame: 2 years
measuring the main change in visual acuity in logarithm of the minimum angle of resolution (log MAR) using projector chart as functional outcome
Secondary Outcomes
- the main change in central macular thickness(2 years)