BEOVU Versus Eylea in the Treatment of Diabetic Macular E... | NCT04955171

Studies
BEOVU Versus Eylea in the Treatment of Diabetic Macular Edema

NCT04955171

Sponsor

Benha University

Status

Unknown status

Last Update Posted

Jul 8, 2021Actual

Enrollment

60Estimated

Phase

Phase 3

Conditions

Macular Edema

Interventions

BEOVU intravitreal injection

Countries

United Arab Emirates

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 12, 2021Actual

Primary Completion Date

Mar 2022Estimated

Completion Date

Apr 2022Estimated

First Submitted Date

Jul 4, 2021

First Submission Date that Met QC Criteria

Jul 4, 2021

First Posted Date

Jul 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2021

Last Update Posted Date

Jul 8, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tarek Roshdy mohamed Mahgoub ELhamaky, Associate Professor, Benha UniversityPrincipal Investigator

Lead Sponsor

Benha UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
BEOVU intravitreal injection	Drug	BEOVU intravitreal injection	BEOVU Eylea

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best corrected visual acuity (BCVA)	Change in BCVA in LOG MARS(logarithm minimum angle of resolution	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetic macular edema

Exclusion Criteria:

other causes of macular edema
other macular diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
TAREK R ELHAMAKY, MD	Contact	+9712 443 8999		thamaky@ibnnafees.com
TAREK ELHAMAKY	Contact	+9712 443 8999		thamaky@ibnnafees.com

Overall Officials

Name	Affiliation	Role
TAREK ELHAMAKY, MD	Benha University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
INMC	Recruiting	Abu Dhabi		46266	United Arab Emirates

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

by direct contact through email

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

UNLIMITED

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008269	Macular Edema

Ancestor Terms

ID	Term
D008268	Macular Degeneration
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided