BEOVU Versus Eylea in the Treatment of Diabetic Macular Edema

Phase 3

• Conditions: Macular Edema
• Interventions: Drug: BEOVU intravitreal injection

• Registration Number: NCT04955171
• Lead Sponsor: Benha University

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)

Study Timeline

• Study Start: 2021-01-12
• Status Verified: 2021-07
• Study First Submitted: 2021-07-04
• Study First Submitted QC: 2021-07-04
• Last Update Submitted: 2021-07-04
• Study First Posted: 2021-07-08
• Last Update Posted: 2021-07-08
• Primary Completion: 2022-03
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Diabetic macular edema

Exclusion Criteria

• other causes of macular edema
• other macular diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eylea	BEOVU intravitreal injection	Intravitreal injection of Eylea 3 loading injections( monthly) then under treat and extent regimen
BEOVU	BEOVU intravitreal injection	Intravitreal injection of BEOVU 3 loading injections( monthly) then under treat and extent regimen

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity (BCVA)	12 months	Change in BCVA in LOG MARS(logarithm minimum angle of resolution

Trial Locations

Locations (1)

INMC; 🇦🇪 Abu Dhabi, United Arab Emirates