Back to resultsBEOVU Versus Eylea in the Treatment of Age-related Macular Neovascular Degeneration
Primary Purpose
Macula Lutea Degeneration
Status
Unknown status
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
intravitreal injection
intravitreal injection
Sponsored by
About this trial
This is an interventional treatment trial for Macula Lutea Degeneration focused on measuring macular degeneration, BEOVU, Eylea
Eligibility Criteria
Inclusion Criteria:
- • Age-Related macular neovascularization degeneration
Exclusion Criteria:
- other causes of macular neovascularization degeneration
- 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 every 3 months
Intravitreal injection of Eylea 3 loading injections ( monthly) then every 3 months
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
NCT04882956
Brief Title
BEOVU Versus Eylea in the Treatment of Age-related Macular Neovascular Degeneration
Official Title
Outcome of Brolucizumab-dbll and Aflibercept Intravitreal Injection in the Treatment of Age-related Macular Neovascular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 5, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
March 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
Age-Related macular neovascularization 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
Macula Lutea Degeneration
Keywords
macular degeneration, BEOVU, Eylea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BEOVU
Arm Type
Active Comparator
Arm Description
Intravitreal injection of BEOVU 3 loading injections ( monthly) then every 3 months
Arm Title
Eylea
Arm Type
Active Comparator
Arm Description
Intravitreal injection of Eylea 3 loading injections ( monthly) then every 3 months
Intervention Type
Drug
Intervention Name(s)
intravitreal injection
Other Intervention Name(s)
BEOVU
Intervention Description
Brolucizumab-Dbll intravitreal injection
Intervention Type
Drug
Intervention Name(s)
intravitreal injection
Other Intervention Name(s)
Eylea
Intervention Description
Aflipercept 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:
• Age-Related macular neovascularization degeneration
Exclusion Criteria:
other causes of macular neovascularization degeneration
other macular diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tarek R Elhamaky, MD
Phone
+97126324200
Email
thamaky@ibnnafees.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tarek Elhamaky, MD
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
IPD Sharing Access Criteria
direct request by email
Learn more about this trial
BEOVU Versus Eylea in the Treatment of Age-related Macular Neovascular Degeneration
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