Back to resultsBEOVU Versus Eylea in the Treatment of Diabetic Macular Edema
Primary Purpose
Macular Edema
Status
Unknown status
Phase
Phase 3
Locations
United Arab Emirates
Study Type
Interventional
Intervention
BEOVU intravitreal injection
Sponsored by
About this trial
This is an interventional treatment trial for Macular Edema focused on measuring BEOVU, Eylea, diabetic macular edema
Eligibility Criteria
Inclusion Criteria:
- Diabetic macular edema
Exclusion Criteria:
- other causes of macular edema
- other macular diseases
Sites / Locations
- INMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
BEOVU
Eylea
Arm Description
Intravitreal injection of BEOVU 3 loading injections( monthly) then under treat and extent regimen
Intravitreal injection of Eylea 3 loading injections( monthly) then under treat and extent regimen
Outcomes
Primary Outcome Measures
Best corrected visual acuity (BCVA)
Change in BCVA in LOG MARS(logarithm minimum angle of resolution
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04955171
Brief Title
BEOVU Versus Eylea in the Treatment of Diabetic Macular Edema
Official Title
Outcome of Brolucizumab-dbll and Aflibercept Intravitreal Injection in the Treatment of Diabetic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Diabetic macular edema degeneration occur is a vision threatening condition. The investigators compare the efficacy of BEOVU and Eylea intravitreal treatment in the management
Detailed Description
Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination was done. Procedure included randomized intravitreal injection of Brolucizumab(BEOVU®, Genentech, South Francisco, CA) and of aflibercept (Eylea;Regeneron, Tarrytown,NY)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema
Keywords
BEOVU, Eylea, diabetic macular edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BEOVU
Arm Type
Active Comparator
Arm Description
Intravitreal injection of BEOVU 3 loading injections( monthly) then under treat and extent regimen
Arm Title
Eylea
Arm Type
Active Comparator
Arm Description
Intravitreal injection of Eylea 3 loading injections( monthly) then under treat and extent regimen
Intervention Type
Drug
Intervention Name(s)
BEOVU intravitreal injection
Other Intervention Name(s)
Brolucizumab-Dbll intravitreal injection
Intervention Description
BEOVU intravitreal injection
Primary Outcome Measure Information:
Title
Best corrected visual acuity (BCVA)
Description
Change in BCVA in LOG MARS(logarithm minimum angle of resolution
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetic macular edema
Exclusion Criteria:
other causes of macular edema
other macular diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
TAREK R ELHAMAKY, MD
Phone
+9712 443 8999
Email
thamaky@ibnnafees.com
First Name & Middle Initial & Last Name or Official Title & Degree
TAREK ELHAMAKY
Phone
+9712 443 8999
Email
thamaky@ibnnafees.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TAREK ELHAMAKY, MD
Organizational Affiliation
Benha Faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
INMC
City
Abu Dhabi
ZIP/Postal Code
46266
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TAREK R ELHAMAKY, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
by direct contact through email
IPD Sharing Time Frame
UNLIMITED
Learn more about this trial
BEOVU Versus Eylea in the Treatment of Diabetic Macular Edema
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