NCT04882956

Brief Summary

Age-Related macular neovascularization 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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

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

August 5, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

1.3 years

First QC Date

May 6, 2021

Last Update Submit

May 11, 2021

Conditions

Macula Lutea Degeneration

Keywords

macular degenerationBEOVUEylea

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 every 3 months

Drug: intravitreal injection

Eylea

ACTIVE COMPARATOR

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

Drug: intravitreal injection

Interventions

intravitreal injectionDRUG

Brolucizumab-Dbll intravitreal injection

Also known as: BEOVU
BEOVU

Eligibility Criteria

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

You may qualify if:

  • Age-Related macular neovascularization degeneration

You may not qualify if:

  • other causes of macular neovascularization degeneration
  • 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 Degeneration

Interventions

Intravitreal Injectionsaflibercept

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Injections, IntraocularInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Tarek Elhamaky, MD

    Benha University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarek R Elhamaky, MD

CONTACT

+97126324200thamaky@ibnnafees.com

Tarek Elhamaky, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor (associate)

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 12, 2021

Study Start

August 5, 2020

Primary Completion

December 1, 2021

Study Completion

March 1, 2022

Last Updated

May 12, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

by direct contact through email

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
unlimited
Access Criteria
direct request by email

Locations

AE(1)