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BEOVU in the Treatment of Dystrophy-related Macular Neovascular Degeneration

Sponsor
Benha University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04690062
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
26.2
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Dystrophy-Related macular neovascularization degeneration occur is a vision threatening condition.The investigators evaluate the efficacy of BEOVU intravitreal treatment.

Condition or Disease Intervention/Treatment Phase
Phase 4

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)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Brolucizumab-dbll (BEOVU®) Intravitreal Injection in the Treatment of Dystrophy-related Macular Neovascular Degeneration
Actual Study Start Date :
Oct 25, 2020
Anticipated Primary Completion Date :
Dec 25, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: BEOVU

Intravitreal injection of BEOVU 3 loading injections ( monthly) then every 3 months

Drug: Brolucizumab-Dbll
intravitreal injection of Brolucizumab (BEOVU)
Other Names:
  • BEOVU

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Best corrected visual acuity (BCVA) [12 months]

      Change in BCVA in LOG MARS(logarithm minimum angle of resolution)

    Secondary Outcome Measures

    1. optical coherence tomography (OCT) foveal thickness [12 months]

      change in foveal thickness measured in micrometer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Dystrophy-Related macular neovascularization degeneration
    Exclusion Criteria:
    • age related macular degeneration , other causes of macular neovascularization degeneration

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 INMC Abu Dhabi United Arab Emirates 46266

    Sponsors and Collaborators

    • Benha University

    Investigators

    • Principal Investigator: Tarek Elhamaky, MD, Benha university faculty of medicine , INMC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tarek Roshdy mohamed Mahgoub ELhamaky, Lecturer of ophthalmology, Benha University
    ClinicalTrials.gov Identifier:
    NCT04690062
    Other Study ID Numbers:
    • Hamaky7
    First Posted:
    Dec 30, 2020
    Last Update Posted:
    Dec 30, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tarek Roshdy mohamed Mahgoub ELhamaky, Lecturer of ophthalmology, Benha University
    macular degeneration
    BEOVU
    RETINAL DYSTROPHY
    Additional relevant MeSH terms:
    Retinal Dystrophies

    Study Results

    No Results Posted as of Dec 30, 2020