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OpenTrials
Completed

NCT Number: NCT05712642

A Dosing Study of Intravitreal Bevacizumab for 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.

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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

Age range

28 week–40 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine Cairo University

Cairo, 11865, Egypt

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Intravitreal Bevacizumab

Drug

Serum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab

Other names: Avastin

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. Occurrence of any adverse events from intravitreal-injection

    Time frame: Within 4 weeks from intravitreal injection

    endophthalmitis , retinal detachment , cataract , vitreous hemorrhage

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Feb 3, 2023
Registry last updated
Feb 3, 2023

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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