- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04882956
BEOVU Versus Eylea in the Treatment of Age-related Macular Neovascular Degeneration
May 11, 2021 updated by: Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University
Outcome of Brolucizumab-dbll and Aflibercept Intravitreal Injection in the Treatment of Age-related Macular Neovascular Degeneration
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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)
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Abu Dhabi, United Arab Emirates, 46266
- Recruiting
- INMC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- • Age-Related macular neovascularization degeneration
Exclusion Criteria:
- other causes of macular neovascularization degeneration
- other macular diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: BEOVU
Intravitreal injection of BEOVU 3 loading injections ( monthly) then every 3 months
|
Brolucizumab-Dbll intravitreal injection
Other Names:
Aflipercept intravitreal injection
Other Names:
|
Active Comparator: Eylea
Intravitreal injection of Eylea 3 loading injections ( monthly) then every 3 months
|
Brolucizumab-Dbll intravitreal injection
Other Names:
Aflipercept intravitreal injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best corrected visual acuity (BCVA)
Time Frame: 12 months
|
Change in BCVA in LOG MARS(logarithm minimum angle of resolution
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: tarek elhamaky, MD, benha faculty of medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 5, 2020
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
March 1, 2022
Study Registration Dates
First Submitted
May 6, 2021
First Submitted That Met QC Criteria
May 11, 2021
First Posted (Actual)
May 12, 2021
Study Record Updates
Last Update Posted (Actual)
May 12, 2021
Last Update Submitted That Met QC Criteria
May 11, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hamaky11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
by direct contact through email
IPD Sharing Time Frame
unlimited
IPD Sharing Access Criteria
direct request by email
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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