Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.

October 15, 2012 updated by: Sivakami A Pai

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Arab Emirates
    • UAE
      • Dubai, UAE, United Arab Emirates
        • Recruiting
        • Dubai Hospital
        • Contact:
          • Sivakami A Pai, MS, DNB, Phd
          • Phone Number: 00971504148256
        • Contact:
        • Principal Investigator:
          • Sivakami A Pai, MS, DNB, Phd
        • Sub-Investigator:
          • Afra M Lootah, MSc, FRCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Avastin
Bevacizumab(Avastin) 0.75mg in 0.03 ml
Procedure: Intravitreal Bevacizumab
Other Names:
  • Intravitreal Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Regression Of ROP
Time Frame: Minimum 6 months follow up after intravitreal Avastin
Minimum 6 months follow up after intravitreal Avastin

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrence of ROP
Time Frame: minimum 6 months of follow up.
minimum 6 months of follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sivakami A Pai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

September 22, 2012

First Submitted That Met QC Criteria

October 15, 2012

First Posted (Estimate)

October 16, 2012

Study Record Updates

Last Update Posted (Estimate)

October 16, 2012

Last Update Submitted That Met QC Criteria

October 15, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Avastin for threshold ROP.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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