BEOVU in the Treatment of Dystrophy-related Macular Neovascular Degeneration

December 26, 2020 updated by: Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University

Brolucizumab-dbll (BEOVU®) Intravitreal Injection in the Treatment of Dystrophy-related Macular Neovascular Degeneration

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

Study Overview

Status

Unknown

Conditions

Intervention / 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)

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

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

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 to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Dystrophy-Related macular neovascularization degeneration

Exclusion Criteria:

  • age related macular degeneration , other causes of macular neovascularization degeneration

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
optical coherence tomography (OCT) foveal thickness
Time Frame: 12 months
change in foveal thickness measured in micrometer
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

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

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)

October 25, 2020

Primary Completion (ANTICIPATED)

December 25, 2022

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

December 21, 2020

First Submitted That Met QC Criteria

December 26, 2020

First Posted (ACTUAL)

December 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 30, 2020

Last Update Submitted That Met QC Criteria

December 26, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hamaky7

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.

Clinical Trials on Dystrophy, Retinal

Clinical Trials on Brolucizumab-Dbll

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe