NCT05033106|UnknownPhase 3DMC
Ranibizumab Vs Bevacizumab for Type 1 Retinopathy of Prematurity
Comparison Between Intravitreal Injection of Ranibizumab and Bevacizumab for Treatment of Type 1 Retinopathy of Prematurity
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Sponsor study identifier
interventional
36
1 country
1
Study Start
September 1, 2020
Actual (reported)Primary Completion
September 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2020
Actual (reported)August 26, 2021
Actual (reported)September 2, 2021
Actual (reported)September 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
• Regression achieved either by single injection or multiple injections or additional laser therapy at 60 weeks postmenstrual age.
regression of plus disease and the active neovessels
60 weeks PMA
• Recurrence of ROP
60 weeks PMA
• The number and kind of adverse events, the number of patients progressing to stage 4 or 5.
60 weeks PMA
• The number of reinjections or laser spots and the number of eyes that need lensectomy and vitrectomy.
60 weeks PMA
• Refractive errors in spherical equivalent in patients who only received anti-VEGF treatment, pattern of fixation and ocular alignment.
60 weeks PMA
0.625 mg/0.025 mL bevacizumab is injected into the vitreous cavity of the left eye
A dose of 0.25 mg/0.025 mL ranibizumab (Lucentis) is injected in the right eye of the infant
• 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Bevacizumab, Ranibizumab
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordZagazig University
Zagazig, 002055, Egypt
Ghada Mahmoud Tawfik Eladawy, Msc
Zagazig University
First Submitted
August 26, 2021
First Posted
September 2, 2021
Study Start
September 1, 2020
Actual (reported)Primary Completion
September 1, 2022
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 2, 2021
Record last verified: 2021-08
International Publishing
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Source: ClinicalTrials.gov.
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