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

Minia University

Status and phase: Completed; Phase 4

Conditions: Diabetic Macular Edema

Treatments: Drug: Ranibizumab; Drug: Aflibercept

Study type: Interventional

Funder types: Other

Identifiers

NCT04087746

Minia University & SFH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

AFLIBERCEPT

Active Comparator group

Description:

Intra-vitreal injection of AFLIBERCEPT

Treatment:

Drug: Aflibercept

RANIBIZUMAB

Active Comparator group

Description:

Intra-vitreal injection of RANIBIZUMAB

Treatment:

Drug: Ranibizumab