A Dosing Study of Intravitreal Bevacizumab for Retinopathy of Prematurity

Phase 3

Completed

• Conditions: Retinopathy of Prematurity
• Interventions: Drug: Intravitreal Bevacizumab

• Registration Number: NCT05712642
• Lead Sponsor: Cairo University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2020-12-30
• Study Completion: 2021-01-28
• Study First Submitted: 2023-01-17
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-01
• Last Update Submitted: 2023-02-01
• Study First Posted: 2023-02-03
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A recieved 0.3125mg intravitreal bevacizumab in both eyes	Intravitreal Bevacizumab	9 infants in group A with type 1 ROP , received 0.3125mg IVI of bevacizumab in both eyes, serum systemic levels of VEGF was measured at day 0 (before injection) , and 1 week and 4 weeks post injection .
Group B received 0.625mg intravitreal bevacizumab in both eyes	Intravitreal Bevacizumab	10 infants in group B with type 1 ROP , received 0.625mg IVI of bevacizumab in both eyes, serum systemic levels of VEGF was measured at day 0 (before injection) , and 1 week and 4 weeks post injection .

Primary Outcome Measures

Name	Time	Method
The number of infants without need for rescue therapy until 60 weeks of postmenstrual age after initial treatment.	"up to 60 weeks postmenstrual age"	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.
Change in the serum systemic VEGF pre- and post- intravitreal injection of bevacizumab in both groups.	at day 0 (baseline ) , 1 week and 4 weeks post-injection	serum systemic VEGF measured using human VEGF ELISA kit

Secondary Outcome Measures

Name	Time	Method
Occurrence of any adverse events from intravitreal-injection	Within 4 weeks from intravitreal injection	endophthalmitis , retinal detachment , cataract , vitreous hemorrhage

Trial Locations

Locations (1)

Faculty of Medicine Cairo University; 🇪🇬 Cairo, Egypt