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Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.

NCT ID: NCT01707745

Last Updated: 2012-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Avastin

Bevacizumab(Avastin) 0.75mg in 0.03 ml

Group Type OTHER

Intravitreal Bevacizumab

Intervention Type PROCEDURE

Interventions

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Intravitreal Bevacizumab

Intervention Type PROCEDURE

Other Intervention Names

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Intravitreal Avastin

Eligibility Criteria

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Inclusion Criteria

Informed written consent by parents or guardian.

\-

Exclusion Criteria

Refusal to give consent Critically ill neonates.

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Minimum Eligible Age

32 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sivakami A Pai

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sivakami A Pai

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Dubai Hospital

Dubai, UAE, United Arab Emirates

Site Status RECRUITING

Countries

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United Arab Emirates

Central Contacts

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Sivakami A Pai, MS, DNB, Phd

Role: CONTACT

Phone: 00971504148256

M A Dekhain, FRCS, MRCOpth

Role: CONTACT

Phone: 0097142195000

Email: [email protected]

Facility Contacts

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Sivakami A Pai, MS, DNB, Phd

Role: primary

Moza A Dekhain, MRCOpthal, FRCS

Role: backup

Other Identifiers

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Avastin for threshold ROP.

Identifier Type: -

Identifier Source: org_study_id