A Dosing Study of Intravitreal Bevacizumab for Retinopathy of Prematurity

Retinopathy of Prematurity Clinical Trial

Official title:

A Dosing Study of Two Different Doses (0.3125mg Versus 0.625mg) Intravitreal Bevacizumab for Type 1 ROP (Retinopathy of Prematurity)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05712642
• Other study ID #: MD-108-2019
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2020
• Est. completion date: January 28, 2021

Study information

• Verified date: February 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of our study was to determine whether a low dose of 0.3125mg intravitreal bevacizumab is effective in treatment of type 1 ROP as the standard 0.625 mg dose., regarding :

Serum Systemic VEGF levels. Retinal Vascularization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 28, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 40 Weeks

Eligibility

Inclusion Criteria:

Infants with Type 1 ROP according to ETROP study which is defined as:

• Zone I ROP with plus disease

• Zone I, stage 3 ROP without plus disease

• Zone II, stage 2 or 3 ROP with plus disease

Exclusion Criteria:

• Eyes with previous intravitreal injection

• Eyes with previous laser therapy

• Eyes with any other intraocular pathology other than ROP (congenital cataract, congenital glaucoma, any retinal pathology other than ROP)

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Drug:
• Intravitreal Bevacizumab
Serum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the serum systemic VEGF pre- and post- intravitreal injection of bevacizumab in both groups.	serum systemic VEGF measured using human VEGF ELISA kit	at day 0 (baseline ) , 1 week and 4 weeks post-injection
Primary	The number of infants without need for rescue therapy until 60 weeks of postmenstrual age after initial treatment.	Rescue therapy is defined as the need of a second dose of 0.625 mg bevacizumab reinjection or laser at any time during follow up period.	"up to 60 weeks postmenstrual age"
Secondary	Occurrence of any adverse events from intravitreal-injection	endophthalmitis , retinal detachment , cataract , vitreous hemorrhage	Within 4 weeks from intravitreal injection