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Ranibizumab Vs Bevacizumab for Type 1 Retinopathy of Prematurity

NCT05033106 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-09-02

No results posted yet for this study

Summary

Retinopathy of prematurity (ROP) with inadequate growth and development of retinal blood vessels in premature infants is one of the foremost reasons for childhood blindness. Recently there is a shift of treatment to VEGF inhibitors which can regress ROP without destroying the peripheral retina. Yet, the best drug has not been identified.Bevacizumab is a larger, full-length immunoglobulin G (IgG) molecule with slower retinal clearance and therefore prolonged diffusion into the systemic circulation, up to 3 weeks. In contrast, the systemic half-life of a Fab molecule, such as ranibizumab, is a few hours. The objective is to compare the efficacy and reliability of intravitreal bevacizumab with standard 0.625 mg dose and intravitreal ranibizumab treatments for type 1 ROP, namely pattern of disease regression, recurrence of ROP, necessity of subsequent ablative procedures.

Conditions

  • Retinopathy of Prematurity Both Eyes

Interventions

DRUG

Bevacizumab, Ranibizumab

• A dose of 0.25 mg/0.025 mL ranibizumab (Lucentis) is injected in the right eye of the infant and 0.625 mg/0.025 mL bevacizumab is injected into the vitreous cavity of the left eye 1 mm posterior to the superior/inferior temporal limbus via 30 G needle. The two injections are done sequentially on two consecutive days starting with the eye of more advanced disease.

Sponsors & Collaborators

  • Cairo University

    collaborator OTHER

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Ghada Mahmoud Tawfik Eladawy, Msc · Zagazig University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-09-01
Completion
2022-09-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05033106 on ClinicalTrials.gov