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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Aflibercept Versus Ranibizumab in Management of Diabetic Macular Edema

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Aflibercept
* Drug: Ranibizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AFLIBERCEPT<br>Intra-vitreal injection of AFLIBERCEPT | Drug: Aflibercept<br>* Intra-vitreal injection of AVEGF AFLIBERCEPT in group I<br>* Other names: Group1;|
| Active Comparator: RANIBIZUMAB<br>Intra-vitreal injection of RANIBIZUMAB | Drug: Ranibizumab<br>* Intra-vitreal injection of AVEGF Ranibizumab in group 2<br>* Other names: Group 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |