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Completed

NCT Number: NCT04087746

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

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.

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Key information

Conditions

Diabetic Macular Edema

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Minia University

Minya, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aflibercept

Drug

Intra-vitreal injection of AVEGF AFLIBERCEPT in group I

Other names: Group1

ranibizumab

Drug

Intra-vitreal injection of AVEGF Ranibizumab in group 2

Other names: Group 2

Primary outcomes

  1. measuring the main change in visual acuity

    Time frame: 2 years

    measuring the main change in visual acuity in logarithm of the minimum angle of resolution (log MAR) using projector chart as functional outcome

Secondary outcomes

  1. the main change in central macular thickness

    Time frame: 2 years

    the main change in central macular thickness in micrometer by using optical coherence tomography (OCT) as anatomical outcome

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Comparison of Aflibercept Versus Ranibizumab in Management of Diabetic Macular Edema

Acronym: DME

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2019
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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