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

NCT ID: NCT04087746

Last Updated: 2019-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-06-30

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.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AFLIBERCEPT

Intra-vitreal injection of AFLIBERCEPT

Group Type: ACTIVE_COMPARATOR

Aflibercept

Intervention Type: DRUG

Intra-vitreal injection of AVEGF AFLIBERCEPT in group I

RANIBIZUMAB

Intra-vitreal injection of RANIBIZUMAB

Group Type: ACTIVE_COMPARATOR

Ranibizumab

Intervention Type: DRUG

Intra-vitreal injection of AVEGF Ranibizumab in group 2

Interventions

Aflibercept

Intra-vitreal injection of AVEGF AFLIBERCEPT in group I

Intervention Type: DRUG

Ranibizumab

Intra-vitreal injection of AVEGF Ranibizumab in group 2

Intervention Type: DRUG

Other Intervention Names

Group1; Group 2

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Shaaban Elwan

Assistant professor of ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaaban AM Elwan, MD

Role: PRINCIPAL_INVESTIGATOR

Minia University

Locations

Minia University

Minya, , Egypt

Countries

Egypt

Other Identifiers

Minia University & SFH

Identifier Type: -

Identifier Source: org_study_id