BEOVU Versus Eylea in the Treatment of Diabetic Macular Edema

July 4, 2021 updated by: Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University

Outcome of Brolucizumab-dbll and Aflibercept Intravitreal Injection in the Treatment of Diabetic Macular Edema

Diabetic macular edema 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)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetic macular edema

Exclusion Criteria:

  • other causes of macular edema
  • 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 under treat and extent regimen
Drug: BEOVU intravitreal injection
BEOVU intravitreal injection
Other Names:
  • Brolucizumab-Dbll intravitreal injection
Active Comparator: Eylea
Intravitreal injection of Eylea 3 loading injections( monthly) then under treat and extent regimen
Drug: BEOVU intravitreal injection
BEOVU intravitreal injection
Other Names:
  • Brolucizumab-Dbll intravitreal injection

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

Benha University

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)

January 12, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

July 4, 2021

First Submitted That Met QC Criteria

July 4, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Actual)

July 8, 2021

Last Update Submitted That Met QC Criteria

July 4, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hamaky15

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 Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (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

product manufactured in and exported from the U.S.

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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