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Completed

NCT Number: NCT04539106

Intravitreal Ranibizumab in Recurrent ROP

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.

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Retinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

intravitreal injection of Ranibizumab

Drug

intravitreal injection of 0.25 mg/0.025 ml ranibizumab with a 30-gauge needle 1.5mm from limbus

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ameera Gamal Abdelhameed

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 4, 2020
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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