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

Diabetic Macular Edema Clinical Trial

— DME  

Official title:

Comparison of Aflibercept Versus Ranibizumab in Management of Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04087746
• Other study ID #: Minia University & SFH
• Status: Completed
• Phase: Phase 4
• Start date: January 2017
• Est. completion date: June 2019

Study information

• Verified date: September 2019
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Aflibercept
Intra-vitreal injection of AVEGF AFLIBERCEPT in group I
• Ranibizumab
Intra-vitreal injection of AVEGF Ranibizumab in group 2

Locations

Country	Name	City	State
Egypt	Minia University	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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