Back to resultsBEOVU in the Treatment of Dystrophy-related Macular Neovascular Degeneration
Primary Purpose
Dystrophy, Retinal
Status
Unknown status
Phase
Phase 4
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Brolucizumab-Dbll
Sponsored by
About this trial
This is an interventional treatment trial for Dystrophy, Retinal focused on measuring macular degeneration, BEOVU, RETINAL DYSTROPHY
Eligibility Criteria
Inclusion Criteria:
- Dystrophy-Related macular neovascularization degeneration
Exclusion Criteria:
- age related macular degeneration , other causes of macular neovascularization degeneration
Sites / Locations
- INMCRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BEOVU
Arm Description
Intravitreal injection of BEOVU 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
optical coherence tomography (OCT) foveal thickness
change in foveal thickness measured in micrometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04690062
Brief Title
BEOVU in the Treatment of Dystrophy-related Macular Neovascular Degeneration
Official Title
Brolucizumab-dbll (BEOVU®) Intravitreal Injection in the Treatment of Dystrophy-related Macular Neovascular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 25, 2020 (Actual)
Primary Completion Date
December 25, 2022 (Anticipated)
Study Completion Date
December 30, 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
Dystrophy-Related macular neovascularization degeneration occur is a vision threatening condition.The investigators evaluate the efficacy of BEOVU intravitreal treatment.
Detailed Description
Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination was done.
Procedure included intravitreal injection of Brolucizumab (BEOVU®, Genen-tech, South Francisco, CA)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystrophy, Retinal
Keywords
macular degeneration, BEOVU, RETINAL DYSTROPHY
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BEOVU
Arm Type
Experimental
Arm Description
Intravitreal injection of BEOVU 3 loading injections ( monthly) then every 3 months
Intervention Type
Drug
Intervention Name(s)
Brolucizumab-Dbll
Other Intervention Name(s)
BEOVU
Intervention Description
intravitreal injection of Brolucizumab (BEOVU)
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
Secondary Outcome Measure Information:
Title
optical coherence tomography (OCT) foveal thickness
Description
change in foveal thickness measured in micrometer
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Dystrophy-Related macular neovascularization degeneration
Exclusion Criteria:
age related macular degeneration , other causes of macular neovascularization degeneration
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tarek R Elhamaky, MD
Phone
+97126324200
Email
thamaky@ibnnafees.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek Elhamaky, MD
Organizational Affiliation
Benha university faculty of medicine , INMC
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 in the Treatment of Dystrophy-related Macular Neovascular Degeneration
We'll reach out to this number within 24 hrs