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

Phase 4

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Aflibercept; Drug: Ranibizumab

• Registration Number: NCT04087746
• Lead Sponsor: Minia University

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.

Study Timeline

• Study Start: 2017-01
• Primary Completion: 2019-01
• Study Completion: 2019-06
• Status Verified: 2019-09
• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-10
• Last Update Submitted: 2019-09-10
• Study First Posted: 2019-09-12
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 .

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AFLIBERCEPT	Aflibercept	Intra-vitreal injection of AFLIBERCEPT
RANIBIZUMAB	Ranibizumab	Intra-vitreal injection of RANIBIZUMAB

Primary Outcome Measures

Name	Time	Method
measuring the main change in visual acuity	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 Outcome Measures

Name	Time	Method
the main change in central macular thickness	2 years	the main change in central macular thickness in micrometer by using optical coherence tomography (OCT) as anatomical outcome

Trial Locations

Locations (1)

Minia University; 🇪🇬 Minya, Egypt