A Dosing Study of Intravitreal Bevacizumab for Retinopathy of Prematurity

February 1, 2023 updated by: Nooran Mohammed Abdelhameed Abdelkader, Cairo University

A Dosing Study of Two Different Doses (0.3125mg Versus 0.625mg) Intravitreal Bevacizumab for Type 1 ROP (Retinopathy of Prematurity)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 3

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

  • Egypt
      • Cairo, Egypt, 11865
        • Faculty of Medicine Cairo University

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

6 months to 9 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A recieved 0.3125mg intravitreal bevacizumab in both eyes
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 .
Drug: Intravitreal Bevacizumab
Serum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab
Other Names:
  • Avastin
ACTIVE_COMPARATOR: Group B received 0.625mg intravitreal bevacizumab in both eyes
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 .
Drug: Intravitreal Bevacizumab
Serum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of any adverse events from intravitreal-injection
Time Frame: Within 4 weeks from intravitreal injection
endophthalmitis , retinal detachment , cataract , vitreous hemorrhage
Within 4 weeks from intravitreal injection

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Nooran Abdelkader, MD, Cairo University

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 (ACTUAL)

February 1, 2020

Primary Completion (ACTUAL)

December 30, 2020

Study Completion (ACTUAL)

January 28, 2021

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (ACTUAL)

February 3, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 3, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-108-2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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