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NCT05712642 Clinical Trial

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
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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)

Study Design

Related Conditions & MeSH terms

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
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