Intravitreal Ranibizumab in Recurrent ROP

August 31, 2020 updated by: Ameera Gamal Abdelhameed

Clinical Outcome Following Reinjection of Ranibizumab in Recurrent Cases With Retinopathy of Prematurity

A retrospective study included reviewing of medical records of preterm babies who were admitted in neonatal intensive care unit (NICU) of Mansoura University children hospital (MUCH) or referred from nearby hospitals for ROP screening during the period from March 2013 to February 2020.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Retinopathy of prematurity was diagnosed and classified according to the International Classification of ROP. Data of the patients who received IVR for type 1 ROP or aggressive posterior ROP (AP-ROP) according to early treatment ROP study (ETROP) were collected. Intravitreal ranibizumab injection was performed as follows; topical anesthetic drop was applied, standard aseptic eye preparation with 5% betadine was performed, a lid speculum was inserted and intravitreal injection of 0.25 mg/0.025 ml ranibizumab with a 30-gauge needle 1.5mm from limbus was given. In case of bilateral ROP, both eyes are injected in the same session. Infants were examined a day after the procedure and weekly thereafter until full vascularization of the retina was observed.

ROP reactivation was defined as any of the following: recurrent plus disease, recurrent neovascularization, or reformation of ridge despite treatment . Once recurrence was determined, second injection of IVR (0.25mg/0.025mL) was given to patients or surgery was performed if progressed to stage 4 or 5. All treated infants were examined until complete regression of ROP and full retinal vascularization.

Study Type

Observational

Enrollment (Actual)

115

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
    • Dakahlia
      • Mansoura, Dakahlia, Egypt
        • Mansoura 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ROP reactivation was defined as any of the following: recurrent plus disease, recurrent neovascularization, or reformation of ridge despite treatment

Description

Inclusion Criteria:

  • patients received IVR for type 1 ROP or aggressive posterior ROP (AP-ROP) according to early treatment ROP study (ETROP) and developed recurrence of ROP

Exclusion Criteria:

-

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
full vascularization of the retina
Time Frame: 6 months
Infants were examined a day after the procedure and weekly thereafter until full vascularization of the retina was observed.
6 months

Collaborators and Investigators

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

Sponsor

Ameera Gamal Abdelhameed

Investigators

  • Principal Investigator: Rania MR Bassiouny, MD, Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2019

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

August 31, 2020

First Posted (Actual)

September 4, 2020

Study Record Updates

Last Update Posted (Actual)

September 4, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • intravitreal Ranibizumab reinj

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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