Ranibizumab Vs Bevacizumab for Type 1 Retinopathy of Prematurity

Sponsor
Zagazig University
Study ID
NCT05033106
Phase
PHASE3
Status
Unknown

Conditions

  • Retinopathy of Prematurity Both Eyes

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab, Ranibizumab — DRUG
    • 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.

Study Details

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.

Key Dates

First listed
Sep 2, 2021
Start date
Sep 1, 2020
Status verified
Aug 2021
Primary completion
Sep 1, 2022
Completion
Sep 1, 2022

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Eyes with IVI bevacizumab
    0.625 mg/0.025 mL bevacizumab is injected into the vitreous cavity of the left eye
  • Active Comparator: Eyes with IVI ranibizumab
    A dose of 0.25 mg/0.025 mL ranibizumab (Lucentis) is injected in the right eye of the infant

Primary Outcome Measure

• Regression achieved either by single injection or multiple injections or additional laser therapy at 60 weeks postmenstrual age. [ Time Frame: 60 weeks PMA ]

Central Contacts