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

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Aflibercept
Ranibizumab
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Minia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

AFLIBERCEPT

RANIBIZUMAB

Arm Description

Intra-vitreal injection of AFLIBERCEPT

Intra-vitreal injection of RANIBIZUMAB

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2019
Last Updated
September 10, 2019
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT04087746
Brief Title
Comparison of Aflibercept Versus Ranibizumab in Management of Diabetic Macular Edema (DME)
Acronym
DME
Official Title
Comparison of Aflibercept Versus Ranibizumab in Management of Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AFLIBERCEPT
Arm Type
Active Comparator
Arm Description
Intra-vitreal injection of AFLIBERCEPT
Arm Title
RANIBIZUMAB
Arm Type
Active Comparator
Arm Description
Intra-vitreal injection of RANIBIZUMAB
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Group1
Intervention Description
Intra-vitreal injection of AVEGF AFLIBERCEPT in group I
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Group 2
Intervention Description
Intra-vitreal injection of AVEGF Ranibizumab in group 2
Primary Outcome Measure Information:
Title
measuring the main change in visual acuity
Description
measuring the main change in visual acuity in logarithm of the minimum angle of resolution (log MAR) using projector chart as functional outcome
Time Frame
2 years
Secondary Outcome Measure Information:
Title
the main change in central macular thickness
Description
the main change in central macular thickness in micrometer by using optical coherence tomography (OCT) as anatomical outcome
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaaban AM Elwan, MD
Organizational Affiliation
Minia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minia University
City
Minya
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
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Comparison of Aflibercept Versus Ranibizumab in Management of Diabetic Macular Edema (DME)

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