Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.

Not Applicable

• Conditions: Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II.
• Interventions: Procedure: Intravitreal Bevacizumab

• Registration Number: NCT01707745
• Lead Sponsor: Sivakami A Pai

Brief Summary

Prospective study to evaluate the efficacy and safety of intravitreal bevacizumab In retinopathy of prematurity (ROP).

Bevacizumab 0.75 mg in 0.03 ml was given to stage 2+ or stage 3+ ROP in Zone I or Zone II.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2012-09-22
• Status Verified: 2012-10
• Study First Submitted QC: 2012-10-15
• Last Update Submitted: 2012-10-15
• Study First Posted: 2012-10-16
• Last Update Posted: 2012-10-16
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

stage 2+ or stage 3+ Retinopathy of prematurity in Zone I or Zone II.

Informed written consent by parents or guardian.

Exclusion Criteria

Refusal to give consent Critically ill neonates.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Avastin	Intravitreal Bevacizumab	Bevacizumab(Avastin) 0.75mg in 0.03 ml

Primary Outcome Measures

Name	Time	Method
Regression Of ROP	Minimum 6 months follow up after intravitreal Avastin

Secondary Outcome Measures

Name	Time	Method
Recurrence of ROP	minimum 6 months of follow up.

Trial Locations

Locations (1)

Dubai Hospital; 🇦🇪 Dubai, UAE, United Arab Emirates