Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.

Sivakami A Pai

Status: Unknown

Conditions: Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II.

Treatments: Procedure: Intravitreal Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01707745

Avastin for threshold ROP.

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 32 to 42 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Avastin

Other group

Description:

Bevacizumab(Avastin) 0.75mg in 0.03 ml

Treatment:

Procedure: Intravitreal Bevacizumab