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

NCT04087746 | Completed Phase 4 DMC

• 1 other identifier: Minia University & SFH
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the main change in central macular thickness

  2 years

Study Arms (2)

AFLIBERCEPT

ACTIVE COMPARATOR

Intra-vitreal injection of AFLIBERCEPT

Drug: Aflibercept

RANIBIZUMAB

ACTIVE COMPARATOR

Intra-vitreal injection of RANIBIZUMAB

Drug: Ranibizumab

Interventions

Aflibercept DRUG

Intra-vitreal injection of AVEGF AFLIBERCEPT in group I

Also known as: Group1

AFLIBERCEPT

Ranibizumab DRUG

Intra-vitreal injection of AVEGF Ranibizumab in group 2

Also known as: Group 2

RANIBIZUMAB

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• Patients with cataract
• Glaucoma patient
• Previous AVEGF injection in less than one year
• Patients not attending all of the scheduled follow up visits

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University

Minya, Egypt

Location

MeSH Terms

Interventions

aflibercept; Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Shaaban AM Elwan, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of ophthalmology

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 12, 2019
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2019
• Last Updated: September 12, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: 2 year
• Access Criteria: Full PDF

Locations

EG (1)