NCT04955171

Brief Summary

Diabetic macular edema degeneration occur is a vision threatening condition. The investigators compare the efficacy of BEOVU and Eylea intravitreal treatment in the management

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

July 8, 2021

Status Verified

July 1, 2021

Enrollment Period

1.1 years

First QC Date

July 4, 2021

Last Update Submit

July 4, 2021

Conditions

Macular Edema

Keywords

BEOVUEyleadiabetic macular edema

Outcome Measures

Primary Outcomes (1)

  • Best corrected visual acuity (BCVA)

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

    12 months

Study Arms (2)

BEOVU

ACTIVE COMPARATOR

Intravitreal injection of BEOVU 3 loading injections( monthly) then under treat and extent regimen

Drug: BEOVU intravitreal injection

Eylea

ACTIVE COMPARATOR

Intravitreal injection of Eylea 3 loading injections( monthly) then under treat and extent regimen

Drug: BEOVU intravitreal injection

Interventions

BEOVU intravitreal injectionDRUG

BEOVU intravitreal injection

Also known as: Brolucizumab-Dbll intravitreal injection
BEOVUEylea

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic macular edema

You may not qualify if:

  • other causes of macular edema
  • other macular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INMC

Abu Dhabi, 46266, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Macular Edema

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • TAREK ELHAMAKY, MD

    Benha University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

TAREK R ELHAMAKY, MD

CONTACT

+9712 443 8999thamaky@ibnnafees.com

TAREK ELHAMAKY

CONTACT

+9712 443 8999thamaky@ibnnafees.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 4, 2021

First Posted

July 8, 2021

Study Start

January 12, 2021

Primary Completion

March 1, 2022

Study Completion

April 1, 2022

Last Updated

July 8, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

by direct contact through email

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
UNLIMITED

Locations

AE(1)