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

Comparison of Aflibercept Versus Ranibizumab in Management of Diabetic Macular Edema

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: Aflibercept; Drug: Ranibizumab

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 Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt
    • Minia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AFLIBERCEPT; Intra-vitreal injection of AFLIBERCEPT	Drug: Aflibercept; Intra-vitreal injection of AVEGF AFLIBERCEPT in group I; Other Names: Group1
Active Comparator: RANIBIZUMAB; Intra-vitreal injection of RANIBIZUMAB	Drug: Ranibizumab; Intra-vitreal injection of AVEGF Ranibizumab in group 2; Other Names: Group 2

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Principal Investigator: Shaaban AM Elwan, MD, Minia University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

• Last Update Posted (Actual): September 12, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab; Aflibercept
• Other Study ID Numbers: Minia University & SFH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All patients provided informed written consent for their medical information to be included in analysis and for publication.
• IPD Sharing Time Frame: 2 year
• IPD Sharing Access Criteria: Full PDF
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No